American Bioproducts Co.
Parsippany, NJ, US
American Bioproducts Co. appears in FDA device records in Parsippany, NJ. FDA records list 79 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 79
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
Showing 50 of 79FDA records hold 79 510(k) clearances for American Bioproducts Co. between 1985 and 1998. The busiest year on record is 1986, with 17. The most recent is 1998, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1985 | 1 |
| 1986 | 17 |
| 1987 | 6 |
| 1988 | 4 |
| 1989 | 2 |
| 1990 | 1 |
| 1991 | 3 |
| 1992 | 10 |
| 1993 | 9 |
| 1994 | 2 |
| 1995 | 14 |
| 1996 | 5 |
| 1997 | 4 |
| 1998 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K983460 | STAR AUTOMATED MULTI-PARAMETRIC ANALYZER | JPA | Substantially Equivalent | |
| K971519 | ASSERACHROM TPA TEST KIT | GGP | Substantially Equivalent | |
| K964728 | STA-LIATEST D-DI TEST KIT | DAP | Substantially Equivalent | |
| K964716 | STA LIATEST CONTROL [N]+[P] KIT | GGN | Substantially Equivalent | |
| K964718 | STA D-DI CALIBRATOR KIT | DAP | Substantially Equivalent | |
| K962675 | STA - LIATEST VWF TEST KIT | GJT | Substantially Equivalent | |
| K962671 | STA-VWF CALIBRATOR KIT | GJT | Substantially Equivalent | |
| K962674 | STA - VWF CONTROL [N]+[P] KIT | GGN | Substantially Equivalent | |
| K961579 | STA COMPACT AUTOMATED MULTI-PARAMETRIC ANALYZER | GKP | Substantially Equivalent | |
| K955040 | AT-III CONTROL PLASMA KIT | GGC | Substantially Equivalent | |
| K954040 | ASSERACHROM TOTAL PROTEIN S KIT | GGP | Substantially Equivalent | |
| K954017 | ASSERACHROM FREE PROTEIN S KIT | GGP | Substantially Equivalent | |
| K943520 | HEPARIN CONTROL KIT | KFF | Unknown | |
| K943519 | HBPM/LMWH CONTROL KIT | KFF | Unknown | |
| K943514 | THE HEPANORM HBPM/LMWH KIT | KFF | Unknown | |
| K952338 | STA-COAG CONTROL [P] PLUS KIT | GGC | Substantially Equivalent | |
| K943516 | ROTACHROM HBPM/LMWH TEST KIT | KFF | Substantially Equivalent | |
| K943515 | ROTACHROM HEPARIN TEST KIT | KFF | Substantially Equivalent | |
| K925433 | THE STACHROM HEPARIN ASSAY KIT | KFF | Substantially Equivalent | |
| K943517 | STACLOT HEPARIN TEST KIT | KFF | Substantially Equivalent | |
| K944279 | AT-III CALIBRATOR | JBQ | Substantially Equivalent | |
| K943518 | STA SYSTEM CONTROL [N] + [P] KIT | GGN | Substantially Equivalent | |
| K941210 | PTT-LT TEST KIT | GGW | Unknown | |
| K942117 | STA AUTOMATED MULTI-PARAMETRIC ANALYZER | GKP | Substantially Equivalent | |
| K934606 | STAGO FACTOR II-DEFICIENT PLASMA | GJT | Substantially Equivalent | |
| K934605 | STAGO FACTOR V-DEFICIENT PLASMA | GJT | Substantially Equivalent | |
| K933432 | STAGO FACTOR IX-DEFICIENT PLASMA | GJT | Substantially Equivalent | |
| K931906 | NEW STACHROM PROTEIN C TEST KIT | GGP | Substantially Equivalent | |
| K933444 | STAGO FACTOR XI-DEFICIENT PLASMA | GJT | Substantially Equivalent | |
| K933441 | STAGO FACTOR X-DEFICIENT PLASMA | GJT | Substantially Equivalent | |
| K933440 | STAGO FACTOR VII-DEFICIENT PLASMA | GJT | Substantially Equivalent | |
| K933438 | STAGO FACTOR XII-DEFICIENT PLASMA | GJT | Substantially Equivalent | |
| K924370 | STACLOT(R) PNP TEST KIT | GGW | Substantially Equivalent | |
| K930959 | FACTOR CONTROL [P] | GGC | Substantially Equivalent | |
| K930923 | COAG-CONTROL | GGC | Substantially Equivalent | |
| K923731 | STACLOT LA TEST KIT | GFO | Substantially Equivalent | |
| K922565 | NEOPLASTINE(R) CI KIT | GJS | Substantially Equivalent | |
| K922174 | COAG-CONTROL [N] KIT | GGN | Substantially Equivalent | |
| K921449 | NEW STACHROM ANTIPLASMIN | GGP | Substantially Equivalent | |
| K920943 | FDP PLASMA TEST KIT | DAP | Substantially Equivalent | |
| K922040 | NEOPLASTINE CI PLUS | GJS | Substantially Equivalent | |
| K922021 | UNICALIBRATOR KIT | GIZ | Substantially Equivalent | |
| K921684 | PTT-LA TEST KIT | GGW | Substantially Equivalent | |
| K921665 | AVK CONTROL I & II | GGC | Substantially Equivalent | |
| K921344 | THROMBO-CALIBRATOR KIT | GGN | Substantially Equivalent | |
| K913424 | STACLOT(R) PROTEIN S TEST KIT | GGP | Substantially Equivalent | |
| K912468 | LIATEST PROTEIN S KIT | GGP | Substantially Equivalent | |
| K905110 | LIATEST(R) AT III TEST KIT | JBQ | Substantially Equivalent | |
| K904297 | ST-4 COAGULATION INSTRUMENT | GKP | Substantially Equivalent | |
| K892859 | THE STAGO VIII DEFICIENT PLASMA KIT | GGP | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- GFOActivated Partial Thromboplastin
- JBXAggregrometer, Platelet
- JBQAntithrombin Iii Quantitation
- KFFAssay, Heparin
- GGCControl, Plasma, Abnormal
- JLAConversion To Creatinine, Creatine
- JBNFibrin Monomer Paracoagulation
- GHHFibrin Split Products
- DAPFibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
- DANFibrinopeptide A, Antigen, Antiserum, Control
- GKPInstrument, Coagulation, Automated
- GGNPlasma, Coagulation Control
- GJTPlasma, Coagulation Factor Deficient
- GIZPlasma, Control, Normal
- LCOPlatelet Factor 4 Radioimmunoassay
- JPASystem, Multipurpose For In Vitro Coagulation Studies
- GGPTest, Qualitative And Quantitative Factor Deficiency
- GJATest, Thrombin Time
- GGWTest, Time, Partial Thromboplastin
- GJSTest, Time, Prothrombin
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain