Medical device manufacturer
Diagnostic Systems Laboratories, Inc.
Diagnostic Systems Laboratories, Inc. holds 94 FDA 510(k) clearances across 40 product codes. Median elapsed review time is 58 days. openFDA lists no recall records naming the company.
Updated · ingest status · JSON
- 510(k) clearances
- 94
- Product codes
- 40
- Median review
- 58 days
- Recall records
- 0
How does FDA spell Diagnostic Systems Laboratories, Inc.?
FDA publishes this company under a single spelling, so nothing needed merging here. Many manufacturers are not so tidy.
Which product codes does Diagnostic Systems Laboratories, Inc. file in?
40 product codes, ranked by how much they file in each.
| Code | Device | Clearances | Median review | Latest |
|---|---|---|---|---|
| CFL | Radioimmunoassay, Human Growth Hormone | 10 | 31 days | |
| CDZ | Radioimmunoassay, Testosterones And Dihydrotestosterone | 7 | 39 days | |
| JKC | Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate) | 7 | 42 days | |
| CEW | Radioimmunoassay, Parathyroid Hormone | 6 | 25 days | |
| CIZ | Radioimmunoassay, Androstenedione | 4 | 24 days | |
| JKR | Radioimmunoassay, Calcitonin | 4 | 32 days | |
| CGI | Radioimmunoassay, Estriol | 3 | 58 days | |
| CGR | Radioimmunoassay, Cortisol | 3 | 23 days | |
| CHP | Radioimmunoassay, Estradiol | 3 | 125 days | |
| CKG | Radioimmunoassay, Acth | 3 | 49 days | |
| JHI | Visual, Pregnancy Hcg, Prescription Use | 3 | 45 days | |
| JZG | System, Test, Beta-2-Microglobulin Immunological | 3 | 99 days | |
| CDP | Radioimmunoassay, Total Triiodothyronine | 2 | 27 days | |
| CFT | Radioimmunoassay, Prolactin (Lactogen) | 2 | 56 days | |
| CGF | Radioimmunoassay, Estrone | 2 | 65 days | |
| CIB | Radioimmunoassay, Angiotensin I And Renin | 2 | 22 days | |
| CJM | Radioimmunoassay, Aldosterone | 2 | 120 days | |
| DBF | Ferritin, Antigen, Antiserum, Control | 2 | 15 days | |
| JLS | Radioimmunoassay, Progesterone | 2 | 24 days | |
| JLW | Radioimmunoassay, Thyroid-Stimulating Hormone | 2 | 56 days | |
| JLX | Radioimmunoassay, 17-Hydroxyprogesterone | 2 | 77 days | |
| LTJ | Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers | 2 | 339 days | |
| CDX | Radioimmunoassay, Total Thyroxine | 1 | 22 days | |
| CEP | Radioimmunoassay, Luteinizing Hormone | 1 | 16 days | |
| CFP | Radioimmunoassay, Immunoreactive Insulin | 1 | 76 days |
Showing the 25 they file in most, of 40.
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 Systems Laboratories, Inc. had a recall?
openFDA lists no recall records naming this company. That is the absence of a record, not a guarantee — and it counts only recalls FDA has published under a spelling we resolved to this company.
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 Systems Laboratories, Inc. cleared recently?
| 510(k) | Device | Code | Decision | Elapsed days |
|---|---|---|---|---|
| K061758 | ACTIVE RENIN IRMA | CIB | 36 | |
| K020945 | AXSYM INTACT PTH, MODEL 2G06 | CEW | 67 | |
| K020128 | ACTIVE FREE BETA-HCG ELISA, MODEL DSL-10-8500 | JHI | 45 | |
| K002128 | ACTIVE INHIBIN-A ELISA, MODEL DSL-10-28100 | NDR | 144 | |
| K001086 | FREE TESTOSTERONE ENZYME IMMUNOASSAY, MODEL DSL-10-4900 | CDZ | 44 | |
| K990138 | DSL ACTIVE AFP ELISA, MODEL DSL-10-8400 | LOJ | 153 | |
| K981871 | C-REACTIVE PROTEIN ELISA, MODEL NUMBER DSL-10-42100 | DCK | 165 | |
| K973244 | ACTIVE PSA IRMA (DSL-9700) | LTJ | 339 | |
| K973243 | ACTIVE PSA ELISA (DSL-10-9700) | LTJ | 339 | |
| K981607 | ACTIVE RENIN IRMA MODEL NUMBER DSL-25100 | CIB | 22 |
Source: openFDA device/510k · retrieved
Watch what Diagnostic Systems Laboratories, Inc. files next
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