Company ยท US
Organon Teknika Corp.
FDA 510(k) clearances and medical device recalls filed under this name, 1980 to 2000. Name variants (Inc, Corp, punctuation) are merged.
130510(k) clearances (0 in 12 months)
1recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| MDB | System, Blood Culturing | 19 |
| FKT | System, Dialysate Delivery, Sorbent Regenerated | 9 |
| JTN | Susceptibility Test Discs, Antimicrobial | 8 |
| FJI | Dialyzer, Capillary, Hollow Fiber | 7 |
| DAP | Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control | 5 |
| GJS | Test, Time, Prothrombin | 5 |
| JPA | System, Multipurpose For In Vitro Coagulation Studies | 5 |
| KOC | Accessories, Blood Circuit, Hemodialysis | 5 |
| LIB | Device, General Purpose, Microbiology, Diagnostic | 4 |
| GKP | Instrument, Coagulation, Automated | 3 |
| JTC | Device, Microtiter Diluting/Dispensing | 3 |
| KOI | Stimulator, Nerve, Peripheral, Electric | 3 |
| FKP | System, Dialysate Delivery, Single Patient | 2 |
| FKQ | System, Dialysate Delivery, Central Multiple Patient | 2 |
| JHJ | Agglutination Method, Human Chorionic Gonadotropin | 2 |
| JJE | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | 2 |
| JNL | Immunochemical, Thyroglobulin Autoantibody | 2 |
| KFF | Assay, Heparin | 2 |
| LFX | Enzyme Linked Immunoabsorbent Assay, Rubella | 2 |
| LGD | Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii | 2 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 20, 2000 | K003104 | BACT/ALERT CSR Organon Teknika Corp. | LJF |
| Jun 7, 2000 | K000492 | MDA D-DIMER Organon Teknika Corp. | DAP |
| Mar 2, 2000 | K000378 | BACT/ALERT MB CULTURE BOTTLE Organon Teknika Corp. | MDB |
| Feb 10, 2000 | K994343 | BACT/ALERT SV Organon Teknika Corp. | MDB |
| Dec 15, 1999 | K993423 | BACT/ALERT SA Organon Teknika Corp. | MDB |
| Dec 14, 1999 | K993576 | BACT/ALERT MP PROCESS BOTTLE Organon Teknika Corp. | MDB |
| Dec 14, 1999 | K993421 | BACT/ALERT SN Organon Teknika Corp. | MDB |
| Sep 24, 1999 | K992432 | BACT/ALERT FN Organon Teknika Corp. | MDB |
| Sep 15, 1999 | K983762 | NUCLISENS CMV PP67 Organon Teknika Corp. | LIN |
| Sep 3, 1999 | K992401 | BACT/ALERT PF Organon Teknika Corp. | MDB |
| Sep 3, 1999 | K992400 | BACTALERT FA Organon Teknika Corp. | MDB |
| Aug 30, 1999 | K992598 | TOF-WATCH SX Organon Teknika Corp. | KOI |
| Aug 30, 1999 | K992596 | TOF-WATCH S Organon Teknika Corp. | KOI |
| Jun 1, 1999 | K991101 | COAG-A-MATE MAX Organon Teknika Corp. | GKP |
| Jan 13, 1999 | K983772 | MB/BACT BLOOD CULTURE BOTTLE Organon Teknika Corp. | MDB |
| Aug 18, 1998 | K982263 | MB/BACT BLOOD CULTURE BOTTLE Organon Teknika Corp. | MDB |
| Jul 24, 1998 | K981736 | BACT/ALERT 3D MICROBIAL DETECTION SYSTEM Organon Teknika Corp. | MDB |
| Apr 16, 1998 | K974776 | MDA D-DIMER Organon Teknika Corp. | DAP |
| Feb 24, 1998 | K974566 | MDA SIMPLASTIN HTF Organon Teknika Corp. | GJS |
| Dec 16, 1997 | K972698 | TOF-WATCH Organon Teknika Corp. | KOI |
| Dec 2, 1997 | K973325 | BACT/ALERT FAN CULTURE BOTTLES Organon Teknika Corp. | MDB |
| Nov 17, 1997 | K973305 | BACT/ALERT CULTURE BOTTLES Organon Teknika Corp. | MDB |
| Mar 18, 1997 | K965076 | MDA HEPARIN ANTI-X ASSAY Organon Teknika Corp. | KFF |
| Mar 18, 1997 | K964934 | THROMBONOSTIKA F1.2 Organon Teknika Corp. | MIF |
| Jan 22, 1997 | K962857 | COAG-A-MATE MTX Organon Teknika Corp. | GKP |
| Jul 22, 1996 | K954468 | MB/BACT MYCROBACTERIA DETECTION SYSTEM Organon Teknika Corp. | MDB |
| Nov 14, 1995 | K951685 | AURAFLEX TESTOSTERONE CALIBRATOR PACK Organon Teknika Corp. | CDZ |
| Oct 6, 1995 | K952608 | MDA SIMPLASTIN LS Organon Teknika Corp. | GJS |
| Aug 25, 1995 | K952607 | AURAFLEX TPO-AB Organon Teknika Corp. | JNL |
| Aug 25, 1995 | K951320 | AURAFLEX TG-AB AND TPO-AB Organon Teknika Corp. | JNL |
| Jun 20, 1995 | K944846 | AURAFLEX B2-MICROGLOBULIN Organon Teknika Corp. | JZG |
| May 8, 1995 | K951630 | AURAFLEX PROGESTERONE 150TEST PACK Organon Teknika Corp. | JLS |
| May 2, 1995 | K951638 | AURAFLEX CK-MB 200TEST PACK, CALIBRATOR PACK Organon Teknika Corp. | JHY |
| Apr 3, 1995 | K946199 | AURAFLEX(R) ESTRADIOL Organon Teknika Corp. | CHP |
| Mar 21, 1995 | K944698 | AURAFLEX PROLACTIN 200 TEST PACK, CALIBRATOR PACK, DILVENT 1 Organon Teknika Corp. | CFT |
| Mar 20, 1995 | K945331 | AURAFLEX HCG Organon Teknika Corp. | DHA |
| Mar 3, 1995 | K945135 | MICROPLATE PROCESSOR 3000 Organon Teknika Corp. | JJE |
| Feb 22, 1995 | K944697 | AURA FLEX FT4 200 TEST PACK, FT4 CALIBRATOR PACK Organon Teknika Corp. | CEC |
| Feb 17, 1995 | K944594 | BACT/ALERT FAN CULTURE BOTTLE Organon Teknika Corp. | MDB |
| Dec 9, 1994 | K944808 | IMX T3 ASSAY Organon Teknika Corp. | CDP |
| Sep 20, 1994 | K943787 | AURATEK FDP Organon Teknika Corp. | DAP |
| Aug 30, 1994 | K935711 | BACT/ALERT FAN AEROBIC CULTURE BOTTLE Organon Teknika Corp. | MDB |
| Aug 26, 1994 | K942443 | AURAFLEX SYSTEMS Organon Teknika Corp. | JJE |
| Jun 2, 1994 | K940637 | PREDICTOR HOME PREGNANCY TEST Organon Teknika Corp. | LCX |
| Apr 21, 1994 | K934324 | OT IGG SORBENT Organon Teknika Corp. | DEW |
| Apr 21, 1994 | K924892 | FIBRINOSTIKA(R) FGDP MICROELISA SYSTEM Organon Teknika Corp. | DAT |
| Feb 9, 1994 | K934593 | BACT/ALERT 120 Organon Teknika Corp. | MDB |
| Feb 7, 1994 | K933939 | BACT/ALERT BLOOD COLLECTION ADAPTER CAP AND INSERT Organon Teknika Corp. | GIM |
| Jan 27, 1994 | K925617 | MDA PROTEIN ASSAY Organon Teknika Corp. | GGP |
| Apr 20, 1993 | K930849 | VERIFY REFERENCE PLASMA AND MDA VERIFY REF. PLASMA Organon Teknika Corp. | JPA |
Newest 50 of 130.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 11, 2019 | Organon Teknika Inc Vitek 2 reagent cards:
a) GN ID, REF 21341,
b) GP ID, REF 21342,
c) ANC ID, REF 21347,
d) AST-GNOR, REF 22000,
e) AST-GP67, REF 22226,
f) AST-P612, REF 22359,
g) AST-XN01, REF 410025,
h) AST-N222, Terminated |
LON | None listed |