Medical device manufacturer
Diagnostic Products Corp.
Diagnostic Products Corp. holds 324 FDA 510(k) clearances across 117 product codes. Median elapsed review time is 50 days. openFDA lists 7 recall records naming the company. FDA publishes it under 4 different spellings, all counted here as one company.
Updated · ingest status · JSON
- 510(k) clearances
- 324
- Product codes
- 117
- Median review
- 50 days
- Recall records
- 7
How does FDA spell Diagnostic Products Corp.?
FDA publishes this company under 4 different spellings across its datasets. Every figure on this page counts all of them as one company, which is why the totals here are higher than a search for any single spelling would give you.
| As FDA published it | Dataset | Matched by |
|---|---|---|
| Diagnostic Products Corp | device/recall | normalised |
| Diagnostic Products Corp. | device/510k | normalised |
| Diagnostic Products Corp. | device/recall | normalised |
| Diagnostic Products Corporation | device/510k | normalised |
Merges are measured against a hand-labelled sample and held above 98% precision. Pairs the matcher is unsure of are queued for a person rather than merged, because two genuinely different firms with similar names is the error that would corrupt every count on this page.
Which product codes does Diagnostic Products Corp. file in?
117 product codes, ranked by how much they file in each.
| Code | Device | Clearances | Median review | Latest |
|---|---|---|---|---|
| DHB | System, Test, Radioallergosorbent (Rast) Immunological | 26 | 77 days | |
| CEW | Radioimmunoassay, Parathyroid Hormone | 10 | 28 days | |
| CDZ | Radioimmunoassay, Testosterones And Dihydrotestosterone | 9 | 48 days | |
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 9 | 37 days | |
| JLW | Radioimmunoassay, Thyroid-Stimulating Hormone | 8 | 48 days | |
| CDD | Radioassay, Vitamin B12 | 6 | 29 days | |
| CDP | Radioimmunoassay, Total Triiodothyronine | 6 | 21 days | |
| CFT | Radioimmunoassay, Prolactin (Lactogen) | 6 | 41 days | |
| DGC | Ige, Antigen, Antiserum, Control | 6 | 51 days | |
| DJG | Enzyme Immunoassay, Opiates | 6 | 43 days | |
| JFH | Acid Phosphatase (Prostatic), Tartrate Inhibited | 6 | 59 days | |
| CEP | Radioimmunoassay, Luteinizing Hormone | 5 | 89 days | |
| CGR | Radioimmunoassay, Cortisol | 5 | 34 days | |
| CHP | Radioimmunoassay, Estradiol | 5 | 77 days | |
| DKZ | Enzyme Immunoassay, Amphetamine | 5 | 54 days | |
| JHI | Visual, Pregnancy Hcg, Prescription Use | 5 | 83 days | |
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | 5 | 20 days | |
| JQW | Station, Pipetting And Diluting, For Clinical Use | 5 | 58 days | |
| CDX | Radioimmunoassay, Total Thyroxine | 4 | 16 days | |
| CGN | Acid, Folic, Radioimmunoassay | 4 | 45 days | |
| GTZ | Antisera, All Groups, Streptococcus Spp. | 4 | 17 days | |
| JHX | Fluorometric Method, Cpk Or Isoenzymes | 4 | 21 days | |
| JKC | Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate) | 4 | 43 days | |
| JLS | Radioimmunoassay, Progesterone | 4 | 48 days | |
| JZO | System, Test, Thyroid Autoantibody | 4 | 42 days |
Showing the 25 they file in most, of 117.
Median review is elapsed calendar days between date received and decision date, as published by FDA. It is not FDA review days — the two differ whenever the agency stops the clock for an additional information request.
Source: openFDA device/510k · retrieved
Has Diagnostic Products Corp. had a recall?
openFDA lists 7 recall records naming this company across its whole history. A recall record covers one firm's corrective action and may span many device lots.
Z-0528-06TerminatedCDZ
The reagent for this kit lot (L2KTW 2,6 126) was manufactured with a raw material that can carryover and interfere with DPC Kit IMMULITE 2000 Estradiol (L2KE2) causing a false elevation in the observed estradiol concentration.
Z-1015-05TerminatedDHX
Adverse trend in stability, controls biased or out of range.
Z-0537-05TerminatedCDD
A low CPS limit was not incorporated in the kit barcode for IMMULITE 2000 Vitamin B12 L2KVB 2, 6 kit lot 186 only.
Z-0324-05TerminatedCFP
Low bias of 10 to 40% at different levels of insulin in samples.
Z-0972-04TerminatedDHX
Instabililty
Showing the 5 most recently initiated of 7.
Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Recall class I is the most serious kind of recall; device class I is the least risky kind of device, and the two are never mixed here.
Source: openFDA device/recall · retrieved
What has Diagnostic Products Corp. cleared recently?
| 510(k) | Device | Code | Decision | Elapsed days |
|---|---|---|---|---|
| K063057 | IMMULITE/IMMULITE 1000, IMMULITE 2000 HIGH SENSITIVITY CRP | NQD | 78 | |
| K063045 | IMMULITE 2000, IMMULITE 2500 VANCOMYCIN | LEH | 62 | |
| K060929 | IMMULITE 2500 VITAMIN B12 MODEL L5KVB2-200 TEST,L5KVB6-600 TEST, IMMULITE 2500 FOLIC ACID MODEL L5KFO2-200 TEST,L5KFO6-6 | CDD | 23 | |
| K053533 | IMMULITE/IMMULITE 1000 TURBO INTACT PTH | CEW | 46 | |
| K034055 | IMMULITE 2500 CK-MB, 2500 MYOGLOBIN, 2500 STAT TROPONIN I | JHX | 22 | |
| K033234 | IMMULITE 2500 AUTOMATED IMMUNOASSAY ANALYZER | DHA | 67 | |
| K032881 | IMMULITE/IMMULITE 1000 TOTAL TESTOSTERONE AND IMMULITE 2000 TOTAL TESTOSTERONE | CDZ | 25 | |
| K023152 | IMMULITE 2000 ALLERGEN-SPECIFIC IGE | DHB | 85 | |
| K023304 | IMMULITE/IMMULITE 1000 CALCITONIN, MODEL LKCL AND IMMULITE 2000 CALCITONIN, MODEL L2KCL | JKR | 67 | |
| K022603 | IMMULITE 1000 AUTOMATED IMMUNOASSAY ANALYZER | CEW | 15 |
Source: openFDA device/510k · retrieved
Watch what Diagnostic Products Corp. files next
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Data on this page comes from FDA's public openFDA API and is US public domain (CC0). DeviceSignal is an independent commercial service and is not affiliated with the U.S. Food and Drug Administration. Information only, not regulatory advice. Verify anything you rely on against open.fda.gov.