Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Organon Teknika Corp. — Predicate Candidate Screening
130 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
67 daysmedian FDA review time
210 days90th percentile
130clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K003104 | BACT/ALERT CSR | Organon Teknika Corp. | 2000-10-20 | 52 | 0 |
| K000492 | MDA D-DIMER | Organon Teknika Corp. | 2000-06-07 | 113 | 0 |
| K000378 | BACT/ALERT MB CULTURE BOTTLE | Organon Teknika Corp. | 2000-03-02 | 24 | 0 |
| K994343 | BACT/ALERT SV | Organon Teknika Corp. | 2000-02-10 | 49 | 0 |
| K993423 | BACT/ALERT SA | Organon Teknika Corp. | 1999-12-15 | 64 | 0 |
| K993421 | BACT/ALERT SN | Organon Teknika Corp. | 1999-12-14 | 63 | 0 |
| K993576 | BACT/ALERT MP PROCESS BOTTLE | Organon Teknika Corp. | 1999-12-14 | 54 | 0 |
| K992432 | BACT/ALERT FN | Organon Teknika Corp. | 1999-09-24 | 65 | 1 |
| K983762 | NUCLISENS CMV PP67 | Organon Teknika Corp. | 1999-09-15 | 324 | 0 |
| K992401 | BACT/ALERT PF | Organon Teknika Corp. | 1999-09-03 | 46 | 0 |
| K992400 | BACTALERT FA | Organon Teknika Corp. | 1999-09-03 | 46 | 0 |
| K992596 | TOF-WATCH S | Organon Teknika Corp. | 1999-08-30 | 27 | 0 |
| K992598 | TOF-WATCH SX | Organon Teknika Corp. | 1999-08-30 | 27 | 0 |
| K991101 | COAG-A-MATE MAX | Organon Teknika Corp. | 1999-06-01 | 61 | 0 |
| K983772 | MB/BACT BLOOD CULTURE BOTTLE | Organon Teknika Corp. | 1999-01-13 | 79 | 0 |
| K982263 | MB/BACT BLOOD CULTURE BOTTLE | Organon Teknika Corp. | 1998-08-18 | 50 | 0 |
| K981736 | BACT/ALERT 3D MICROBIAL DETECTION SYSTEM | Organon Teknika Corp. | 1998-07-24 | 67 | 2 |
| K974776 | MDA D-DIMER | Organon Teknika Corp. | 1998-04-16 | 115 | 0 |
| K974566 | MDA SIMPLASTIN HTF | Organon Teknika Corp. | 1998-02-24 | 81 | 1 |
| K972698 | TOF-WATCH | Organon Teknika Corp. | 1997-12-16 | 151 | 0 |
| K973325 | BACT/ALERT FAN CULTURE BOTTLES | Organon Teknika Corp. | 1997-12-02 | 89 | 0 |
| K973305 | BACT/ALERT CULTURE BOTTLES | Organon Teknika Corp. | 1997-11-17 | 75 | 0 |
| K964934 | THROMBONOSTIKA F1.2 | Organon Teknika Corp. | 1997-03-18 | 99 | 0 |
| K965076 | MDA HEPARIN ANTI-X ASSAY | Organon Teknika Corp. | 1997-03-18 | 89 | 0 |
| K962857 | COAG-A-MATE MTX | Organon Teknika Corp. | 1997-01-22 | 184 | 0 |
| K954468 | MB/BACT MYCROBACTERIA DETECTION SYSTEM | Organon Teknika Corp. | 1996-07-22 | 300 | 2 |
| K951685 | AURAFLEX TESTOSTERONE CALIBRATOR PACK | Organon Teknika Corp. | 1995-11-14 | 218 | 0 |
| K952608 | MDA SIMPLASTIN LS | Organon Teknika Corp. | 1995-10-06 | 121 | 0 |
| K951320 | AURAFLEX TG-AB AND TPO-AB | Organon Teknika Corp. | 1995-08-25 | 155 | 0 |
| K952607 | AURAFLEX TPO-AB | Organon Teknika Corp. | 1995-08-25 | 86 | 0 |
| K944846 | AURAFLEX B2-MICROGLOBULIN | Organon Teknika Corp. | 1995-06-20 | 263 | 0 |
| K951630 | AURAFLEX PROGESTERONE 150TEST PACK | Organon Teknika Corp. | 1995-05-08 | 31 | 0 |
| K951638 | AURAFLEX CK-MB 200TEST PACK, CALIBRATOR PACK | Organon Teknika Corp. | 1995-05-02 | 22 | 0 |
| K946199 | AURAFLEX(R) ESTRADIOL | Organon Teknika Corp. | 1995-04-03 | 104 | 0 |
| K944698 | AURAFLEX PROLACTIN 200 TEST PACK, CALIBRATOR PACK, DILVENT 1 | Organon Teknika Corp. | 1995-03-21 | 179 | 0 |
| K945331 | AURAFLEX HCG | Organon Teknika Corp. | 1995-03-20 | 139 | 0 |
| K945135 | MICROPLATE PROCESSOR 3000 | Organon Teknika Corp. | 1995-03-03 | 134 | 0 |
| K944697 | AURA FLEX FT4 200 TEST PACK, FT4 CALIBRATOR PACK | Organon Teknika Corp. | 1995-02-22 | 152 | 0 |
| K944594 | BACT/ALERT FAN CULTURE BOTTLE | Organon Teknika Corp. | 1995-02-17 | 151 | 0 |
| K944808 | IMX T3 ASSAY | Organon Teknika Corp. | 1994-12-09 | 71 | 0 |
| K943787 | AURATEK FDP | Organon Teknika Corp. | 1994-09-20 | 48 | 0 |
| K935711 | BACT/ALERT FAN AEROBIC CULTURE BOTTLE | Organon Teknika Corp. | 1994-08-30 | 273 | 0 |
| K942443 | AURAFLEX SYSTEMS | Organon Teknika Corp. | 1994-08-26 | 95 | 0 |
| K940637 | PREDICTOR HOME PREGNANCY TEST | Organon Teknika Corp. | 1994-06-02 | 108 | 0 |
| K934324 | OT IGG SORBENT | Organon Teknika Corp. | 1994-04-21 | 230 | 0 |
| K924892 | FIBRINOSTIKA(R) FGDP MICROELISA SYSTEM | Organon Teknika Corp. | 1994-04-21 | 569 | 0 |
| K934593 | BACT/ALERT 120 | Organon Teknika Corp. | 1994-02-09 | 138 | 2 |
| K933939 | BACT/ALERT BLOOD COLLECTION ADAPTER CAP AND INSERT | Organon Teknika Corp. | 1994-02-07 | 179 | 1 |
| K925617 | MDA PROTEIN ASSAY | Organon Teknika Corp. | 1994-01-27 | 447 | 0 |
| K930849 | VERIFY REFERENCE PLASMA AND MDA VERIFY REF. PLASMA | Organon Teknika Corp. | 1993-04-20 | 61 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda