Medical device manufacturer
Organon Teknika Inc
Organon Teknika Inc holds 130 FDA 510(k) clearances across 56 product codes. Median elapsed review time is 66 days. openFDA lists 1 recall record naming the company. FDA publishes it under 3 different spellings, all counted here as one company.
Updated · ingest status · JSON
- 510(k) clearances
- 130
- Product codes
- 56
- Median review
- 66 days
- Recall records
- 1
How does FDA spell Organon Teknika Inc?
FDA publishes this company under 3 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 |
|---|---|---|
| Organon Teknika Corp. | device/510k | normalised |
| Organon Teknika Inc | device/recall | normalised |
| Organon Teknika Inc | device/enforcement | 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 Organon Teknika Inc file in?
56 product codes, ranked by how much they file in each.
| Code | Device | Clearances | Median review | Latest |
|---|---|---|---|---|
| MDB | System, Blood Culturing | 19 | 67 days | |
| FKT | System, Dialysate Delivery, Sorbent Regenerated | 9 | 78 days | |
| JTN | Susceptibility Test Discs, Antimicrobial | 8 | 17 days | |
| FJI | Dialyzer, Capillary, Hollow Fiber | 7 | 33 days | |
| DAP | Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control | 5 | 113 days | |
| GJS | Test, Time, Prothrombin | 5 | 51 days | |
| JPA | System, Multipurpose For In Vitro Coagulation Studies | 5 | 48 days | |
| KOC | Accessories, Blood Circuit, Hemodialysis | 5 | 70 days | |
| LIB | Device, General Purpose, Microbiology, Diagnostic | 4 | 64 days | |
| GKP | Instrument, Coagulation, Automated | 3 | 61 days | |
| JTC | Device, Microtiter Diluting/Dispensing | 3 | 70 days | |
| KOI | Stimulator, Nerve, Peripheral, Electric | 3 | 27 days | |
| FKP | System, Dialysate Delivery, Single Patient | 2 | 28 days | |
| FKQ | System, Dialysate Delivery, Central Multiple Patient | 2 | 47 days | |
| JHJ | Agglutination Method, Human Chorionic Gonadotropin | 2 | 49 days | |
| JJE | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | 2 | 95 days | |
| JNL | Immunochemical, Thyroglobulin Autoantibody | 2 | 86 days | |
| KFF | Assay, Heparin | 2 | 62 days | |
| LFX | Enzyme Linked Immunoabsorbent Assay, Rubella | 2 | 31 days | |
| LGD | Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii | 2 | 91 days | |
| MIF | Prothrombin Fragment 1.2 | 2 | 99 days | |
| CAK | Microfilter, Blood Transfusion | 1 | 49 days | |
| CDP | Radioimmunoassay, Total Triiodothyronine | 1 | 71 days | |
| CDZ | Radioimmunoassay, Testosterones And Dihydrotestosterone | 1 | 218 days | |
| CEC | Radioimmunoassay, Free Thyroxine | 1 | 152 days |
Showing the 25 they file in most, of 56.
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 Organon Teknika Inc had a recall?
openFDA lists 1 recall record naming this company across its whole history. A recall record covers one firm's corrective action and may span many device lots.
Z-0962-2019Class IITerminatedLON
This notice has been initiated due to potential for compromised test card Top Seal Integrity which could: - yield false resistance for antibiotics on the AST panel - cause a false negative ESBL Test - result in a false positive urea (URE) reaction on ID cards
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 Organon Teknika Inc cleared recently?
| 510(k) | Device | Code | Decision | Elapsed days |
|---|---|---|---|---|
| K003104 | BACT/ALERT CSR | LJF | 52 | |
| K000492 | MDA D-DIMER | DAP | 113 | |
| K000378 | BACT/ALERT MB CULTURE BOTTLE | MDB | 24 | |
| K994343 | BACT/ALERT SV | MDB | 49 | |
| K993423 | BACT/ALERT SA | MDB | 64 | |
| K993576 | BACT/ALERT MP PROCESS BOTTLE | MDB | 54 | |
| K993421 | BACT/ALERT SN | MDB | 63 | |
| K992432 | BACT/ALERT FN | MDB | 65 | |
| K983762 | NUCLISENS CMV PP67 | LIN | 324 | |
| K992401 | BACT/ALERT PF | MDB | 46 |
Source: openFDA device/510k · retrieved
Watch what Organon Teknika Inc 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.