American Bioproducts Co.
Medical device manufacturer in Parisppany, NJ.
79510(k) clearances
0PMA approvals
0recalls
Device types
- GGP Test, Qualitative And Quantitative Factor… 22
- GJT Plasma, Coagulation Factor Deficient 9
- KFF Assay, Heparin 8
- GGC Control, Plasma, Abnormal 5
- GGN Plasma, Coagulation Control 5
- GGW Test, Time, Partial Thromboplastin 4
- DAP Fibrinogen And Fibrin Split Products… 4
- GJS Test, Time, Prothrombin 3
- GKP Instrument, Coagulation, Automated 3
- GHH Fibrin Split Products 3
- GJA Test, Thrombin Time 2
- JBQ Antithrombin Iii Quantitation 2
- JBX Aggregrometer, Platelet 1
- LCO Platelet Factor 4 Radioimmunoassay 1
- JBN Fibrin Monomer Paracoagulation 1
- DAN Fibrinopeptide A, Antigen, Antiserum, Control 1
- GIZ Plasma, Control, Normal 1
- GFO Activated Partial Thromboplastin 1
- JLA Conversion To Creatinine, Creatine 1
- JPA System, Multipurpose For In Vitro… 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K983460 | Star Automated Multi-Parametric AnalyzerJPA · Traditional | 11/12/1998SE |
| K971519 | Asserachrom Tpa Test KitGGP · Traditional | 08/19/1997SE |
| K964728 | Sta-Liatest D-Di Test KitDAP · Traditional | 06/26/1997SE |
| K964716 | Sta Liatest Control [N]+[P] KitGGN · Traditional | 06/26/1997SE |
| K964718 | Sta D-Di Calibrator KitDAP · Traditional | 05/23/1997SE |
| K962675 | Sta - Liatest VWF Test KitGJT · Traditional | 10/25/1996SE |
| K962671 | Sta-Vwf Calibrator KitGJT · Traditional | 09/13/1996SE |
| K962674 | Sta - VWF Control [N]+[P] KitGGN · Traditional | 07/23/1996SE |
| K961579 | Sta Compact Automated Multi-Parametric AnalyzerGKP · Traditional | 07/10/1996SE |
| K955040 | At-Iii Control Plasma KitGGC · Traditional | 01/31/1996SE |
| K954040 | Asserachrom Total Protein S KitGGP · Traditional | 11/13/1995SE |
| K954017 | Asserachrom Free Protein S KitGGP · Traditional | 11/13/1995SE |
| K943520 | Heparin Control KitKFF · Traditional | 09/26/1995SESK |
| K943519 | Hbpm/Lmwh Control KitKFF · Traditional | 09/26/1995SESK |
| K943514 | The Hepanorm Hbpm/Lmwh KitKFF · Traditional | 09/26/1995SESK |
| K952338 | Sta-Coag Control [P] Plus KitGGC · Traditional | 09/21/1995SE |
| K943516 | Rotachrom Hbpm/Lmwh Test KitKFF · Traditional | 08/31/1995SE |
| K943515 | Rotachrom Heparin Test KitKFF · Traditional | 08/31/1995SE |
| K925433 | The Stachrom Heparin Assay KitKFF · Traditional | 05/23/1995SE |
| K943517 | Staclot Heparin Test KitKFF · Traditional | 05/11/1995SE |
| K944279 | At-Iii CalibratorJBQ · Traditional | 04/07/1995SE |
| K943518 | Sta System Control [N] + [P] KitGGN · Traditional | 03/21/1995SE |
| K941210 | Ptt-Lt Test KitGGW · Traditional | 03/21/1995SESK |
| K942117 | Sta Automated Multi-Parametric AnalyzerGKP · Traditional | 02/01/1995SE |
| K934606 | Stago Factor Ii-Deficient PlasmaGJT · Traditional | 03/01/1994SE |
| K934605 | Stago Factor V-Deficient PlasmaGJT · Traditional | 03/01/1994SE |
| K933432 | Stago Factor Ix-Deficient PlasmaGJT · Traditional | 11/15/1993SE |
| K931906 | New Stachrom Protein C Test KitGGP · Traditional | 11/05/1993SE |
| K933444 | Stago Factor Xi-Deficient PlasmaGJT · Traditional | 10/27/1993SE |
| K933441 | Stago Factor X-Deficient PlasmaGJT · Traditional | 10/27/1993SE |
| K933440 | Stago Factor Vii-Deficient PlasmaGJT · Traditional | 10/27/1993SE |
| K933438 | Stago Factor Xii-Deficient PlasmaGJT · Traditional | 10/27/1993SE |
| K924370 | Staclot(R) PNP Test KitGGW · Traditional | 08/09/1993SE |
| K930959 | Factor Control [P]GGC · Traditional | 05/20/1993SE |
| K930923 | Coag-ControlGGC · Traditional | 04/27/1993SE |
| K923731 | Staclot la Test KitGFO · Traditional | 12/23/1992SE |
| K922565 | Neoplastine(R) Ci KitGJS · Traditional | 12/07/1992SE |
| K922174 | Coag-Control [N] KitGGN · Traditional | 10/26/1992SE |
| K921449 | New Stachrom AntiplasminGGP · Traditional | 09/23/1992SE |
| K920943 | FDP Plasma Test KitDAP · Traditional | 07/13/1992SE |
| K922040 | Neoplastine Ci PlusGJS · Traditional | 06/23/1992SE |
| K922021 | Unicalibrator KitGIZ · Traditional | 06/09/1992SE |
| K921684 | Ptt-La Test KitGGW · Traditional | 06/09/1992SE |
| K921665 | Avk Control I & IIGGC · Traditional | 06/09/1992SE |
| K921344 | Thrombo-Calibrator KitGGN · Traditional | 06/09/1992SE |
| K913424 | Staclot(R) Protein S Test KitGGP · Traditional | 10/08/1991SE |
| K912468 | Liatest Protein S KitGGP · Traditional | 10/02/1991SE |
| K905110 | Liatest(R) at III Test KitJBQ · Traditional | 01/24/1991SE |
| K904297 | ST-4 Coagulation InstrumentGKP · Traditional | 11/13/1990SE |
| K892859 | The Stago Viii Deficient Plasma KitGGP · Traditional | 06/23/1989SE |
| K890399 | Modified D-Di-Test KitGHH · Traditional | 02/07/1989SE |
| K884385 | Fibri-Prest/Thrombin-Prest ControlsGJA · Traditional | 12/28/1988SE |
| K884384 | Thrombin-Prest Reagent KitGJA · Traditional | 12/28/1988SE |
| K882603 | Stachrom Antiplasmin ControlGGP · Traditional | 09/02/1988SE |
| K882602 | Stachrom Antiplasmin Test KitGGP · Traditional | 09/02/1988SE |
| K874097 | Stachrom Viii:C Test KitGGP · Traditional | 12/03/1987SE |
| K872479 | Asserachrom Protein S Test KitGGP · Traditional | 08/21/1987SE |
| K871039 | Stachrom Protein C Test KitGGP · Traditional | 05/21/1987SE |
| K870917 | Protein S Control PlasmaGGP · Traditional | 04/23/1987SE |
| K870042 | Assera-Plate Protein S Kit · Traditional | 02/13/1987SE |
| K864392 | Protime Automate Test KitGJS · Traditional | 01/05/1987SE |
| K862775 | Asserachrom B-Tg KitJBX · Traditional | 10/22/1986SE |
| K862156 | Asserachrom D-Di KitDAP · Traditional | 09/16/1986SE |
| K862774 | Asserachrom PF4 KitLCO · Traditional | 09/04/1986SE |
| K861973 | D-Di Test KitGHH · Traditional | 09/04/1986SE |
| K861475 | Assera-Plate Protein C KitGGP · Traditional | 06/25/1986SE |
| K861417 | Assera-Plate VWF KitGGP · Traditional | 06/25/1986SE |
| K861190 | PTT Automate Test KitGGW · Traditional | 06/23/1986SE |
| K861079 | Staclot Protein C Test KitGGP · Traditional | 06/19/1986SE |
| K861217 | Vwf-Ix:Ag Control PlasmaGGP · Traditional | 05/20/1986SE |
| K861216 | Protein C Control PlasmaGGP · Traditional | 05/16/1986SE |
| K860371 | Asserachrom VWF KitGGP · Traditional | 04/04/1986SE |
| K854015 | FS Test KitJBN · Traditional | 03/06/1986SE |
| K854762 | Hepanorm Calibration Plasma SetKFF · Traditional | 03/03/1986SE |
| K854384 | Asserachrom Fpa KitDAN · Traditional | 02/04/1986SE |
| K854312 | Asserachrom Ix:AgGGP · Traditional | 02/04/1986SE |
| K854016 | Asserachrom Protein C KitJLA · Traditional | 01/03/1986SE |
| K854014 | Assera Plate Ix:Ag KitGGP · Traditional | 01/03/1986SE |
| K852848 | FDP ASSAY-20 Test KitGHH · Traditional | 10/10/1985SE |