Organon Teknika Inc
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 130
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-0962-2019 | Class II | Vitek 2 reagent cards: a) GN ID, REF 21341, b) GP ID, REF 21342, c) ANC ID, REF 21347, d) AST-G | January 11, 2019 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K003104 | BACT/ALERT CSR | October 20, 2000 |
| K000492 | MDA D-DIMER | June 7, 2000 |
| K000378 | BACT/ALERT MB CULTURE BOTTLE | March 2, 2000 |
| K994343 | BACT/ALERT SV | February 10, 2000 |
| K993423 | BACT/ALERT SA | December 15, 1999 |
| K993421 | BACT/ALERT SN | December 14, 1999 |
| K993576 | BACT/ALERT MP PROCESS BOTTLE | December 14, 1999 |
| K992432 | BACT/ALERT FN | September 24, 1999 |
| K983762 | NUCLISENS CMV PP67 | September 15, 1999 |
| K992401 | BACT/ALERT PF | September 3, 1999 |
| K992400 | BACTALERT FA | September 3, 1999 |
| K992598 | TOF-WATCH SX | August 30, 1999 |
| K992596 | TOF-WATCH S | August 30, 1999 |
| K991101 | COAG-A-MATE MAX | June 1, 1999 |
| K983772 | MB/BACT BLOOD CULTURE BOTTLE | January 13, 1999 |
| K982263 | MB/BACT BLOOD CULTURE BOTTLE | August 18, 1998 |
| K981736 | BACT/ALERT 3D MICROBIAL DETECTION SYSTEM | July 24, 1998 |
| K974776 | MDA D-DIMER | April 16, 1998 |
| K974566 | MDA SIMPLASTIN HTF | February 24, 1998 |
| K972698 | TOF-WATCH | December 16, 1997 |