Company ยท US
American Bioproducts Co.
FDA 510(k) clearances and medical device recalls filed under this name, 1985 to 1998. Name variants (Inc, Corp, punctuation) are merged.
79510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| GGP | Test, Qualitative And Quantitative Factor Deficiency | 22 |
| GJT | Plasma, Coagulation Factor Deficient | 9 |
| KFF | Assay, Heparin | 8 |
| GGC | Control, Plasma, Abnormal | 5 |
| GGN | Plasma, Coagulation Control | 5 |
| DAP | Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control | 4 |
| GGW | Test, Time, Partial Thromboplastin | 4 |
| GHH | Fibrin Split Products | 3 |
| GJS | Test, Time, Prothrombin | 3 |
| GKP | Instrument, Coagulation, Automated | 3 |
| GJA | Test, Thrombin Time | 2 |
| JBQ | Antithrombin Iii Quantitation | 2 |
| DAN | Fibrinopeptide A, Antigen, Antiserum, Control | 1 |
| GFO | Activated Partial Thromboplastin | 1 |
| GIZ | Plasma, Control, Normal | 1 |
| JBN | Fibrin Monomer Paracoagulation | 1 |
| JBX | Aggregrometer, Platelet | 1 |
| JLA | Conversion To Creatinine, Creatine | 1 |
| JPA | System, Multipurpose For In Vitro Coagulation Studies | 1 |
| LCO | Platelet Factor 4 Radioimmunoassay | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 12, 1998 | K983460 | STAR AUTOMATED MULTI-PARAMETRIC ANALYZER American Bioproducts Co. | JPA |
| Aug 19, 1997 | K971519 | ASSERACHROM TPA TEST KIT American Bioproducts Co. | GGP |
| Jun 26, 1997 | K964728 | STA-LIATEST D-DI TEST KIT American Bioproducts Co. | DAP |
| Jun 26, 1997 | K964716 | STA LIATEST CONTROL [N]+[P] KIT American Bioproducts Co. | GGN |
| May 23, 1997 | K964718 | STA D-DI CALIBRATOR KIT American Bioproducts Co. | DAP |
| Oct 25, 1996 | K962675 | STA - LIATEST VWF TEST KIT American Bioproducts Co. | GJT |
| Sep 13, 1996 | K962671 | STA-VWF CALIBRATOR KIT American Bioproducts Co. | GJT |
| Jul 23, 1996 | K962674 | STA - VWF CONTROL [N]+[P] KIT American Bioproducts Co. | GGN |
| Jul 10, 1996 | K961579 | STA COMPACT AUTOMATED MULTI-PARAMETRIC ANALYZER American Bioproducts Co. | GKP |
| Jan 31, 1996 | K955040 | AT-III CONTROL PLASMA KIT American Bioproducts Co. | GGC |
| Nov 13, 1995 | K954040 | ASSERACHROM TOTAL PROTEIN S KIT American Bioproducts Co. | GGP |
| Nov 13, 1995 | K954017 | ASSERACHROM FREE PROTEIN S KIT American Bioproducts Co. | GGP |
| Sep 26, 1995 | K943520 | HEPARIN CONTROL KIT American Bioproducts Co. | KFF |
| Sep 26, 1995 | K943519 | HBPM/LMWH CONTROL KIT American Bioproducts Co. | KFF |
| Sep 26, 1995 | K943514 | THE HEPANORM HBPM/LMWH KIT American Bioproducts Co. | KFF |
| Sep 21, 1995 | K952338 | STA-COAG CONTROL [P] PLUS KIT American Bioproducts Co. | GGC |
| Aug 31, 1995 | K943516 | ROTACHROM HBPM/LMWH TEST KIT American Bioproducts Co. | KFF |
| Aug 31, 1995 | K943515 | ROTACHROM HEPARIN TEST KIT American Bioproducts Co. | KFF |
| May 23, 1995 | K925433 | THE STACHROM HEPARIN ASSAY KIT American Bioproducts Co. | KFF |
| May 11, 1995 | K943517 | STACLOT HEPARIN TEST KIT American Bioproducts Co. | KFF |
| Apr 7, 1995 | K944279 | AT-III CALIBRATOR American Bioproducts Co. | JBQ |
| Mar 21, 1995 | K943518 | STA SYSTEM CONTROL [N] + [P] KIT American Bioproducts Co. | GGN |
| Mar 21, 1995 | K941210 | PTT-LT TEST KIT American Bioproducts Co. | GGW |
| Feb 1, 1995 | K942117 | STA AUTOMATED MULTI-PARAMETRIC ANALYZER American Bioproducts Co. | GKP |
| Mar 1, 1994 | K934606 | STAGO FACTOR II-DEFICIENT PLASMA American Bioproducts Co. | GJT |
| Mar 1, 1994 | K934605 | STAGO FACTOR V-DEFICIENT PLASMA American Bioproducts Co. | GJT |
| Nov 15, 1993 | K933432 | STAGO FACTOR IX-DEFICIENT PLASMA American Bioproducts Co. | GJT |
| Nov 5, 1993 | K931906 | NEW STACHROM PROTEIN C TEST KIT American Bioproducts Co. | GGP |
| Oct 27, 1993 | K933444 | STAGO FACTOR XI-DEFICIENT PLASMA American Bioproducts Co. | GJT |
| Oct 27, 1993 | K933441 | STAGO FACTOR X-DEFICIENT PLASMA American Bioproducts Co. | GJT |
| Oct 27, 1993 | K933440 | STAGO FACTOR VII-DEFICIENT PLASMA American Bioproducts Co. | GJT |
| Oct 27, 1993 | K933438 | STAGO FACTOR XII-DEFICIENT PLASMA American Bioproducts Co. | GJT |
| Aug 9, 1993 | K924370 | STACLOT(R) PNP TEST KIT American Bioproducts Co. | GGW |
| May 20, 1993 | K930959 | FACTOR CONTROL [P] American Bioproducts Co. | GGC |
| Apr 27, 1993 | K930923 | COAG-CONTROL American Bioproducts Co. | GGC |
| Dec 23, 1992 | K923731 | STACLOT LA TEST KIT American Bioproducts Co. | GFO |
| Dec 7, 1992 | K922565 | NEOPLASTINE(R) CI KIT American Bioproducts Co. | GJS |
| Oct 26, 1992 | K922174 | COAG-CONTROL [N] KIT American Bioproducts Co. | GGN |
| Sep 23, 1992 | K921449 | NEW STACHROM ANTIPLASMIN American Bioproducts Co. | GGP |
| Jul 13, 1992 | K920943 | FDP PLASMA TEST KIT American Bioproducts Co. | DAP |
| Jun 23, 1992 | K922040 | NEOPLASTINE CI PLUS American Bioproducts Co. | GJS |
| Jun 9, 1992 | K922021 | UNICALIBRATOR KIT American Bioproducts Co. | GIZ |
| Jun 9, 1992 | K921684 | PTT-LA TEST KIT American Bioproducts Co. | GGW |
| Jun 9, 1992 | K921665 | AVK CONTROL I & II American Bioproducts Co. | GGC |
| Jun 9, 1992 | K921344 | THROMBO-CALIBRATOR KIT American Bioproducts Co. | GGN |
| Oct 8, 1991 | K913424 | STACLOT(R) PROTEIN S TEST KIT American Bioproducts Co. | GGP |
| Oct 2, 1991 | K912468 | LIATEST PROTEIN S KIT American Bioproducts Co. | GGP |
| Jan 24, 1991 | K905110 | LIATEST(R) AT III TEST KIT American Bioproducts Co. | JBQ |
| Nov 13, 1990 | K904297 | ST-4 COAGULATION INSTRUMENT American Bioproducts Co. | GKP |
| Jun 23, 1989 | K892859 | THE STAGO VIII DEFICIENT PLASMA KIT American Bioproducts Co. | GGP |
Newest 50 of 79.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||