Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
American Bioproducts Co. — Predicate Candidate Screening
79 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
97 daysmedian FDA review time
346 days90th percentile
79clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K983460 | STAR AUTOMATED MULTI-PARAMETRIC ANALYZER | American Bioproducts Co. | 1998-11-12 | 43 | 1 |
| K971519 | ASSERACHROM TPA TEST KIT | American Bioproducts Co. | 1997-08-19 | 116 | 0 |
| K964716 | STA LIATEST CONTROL [N]+[P] KIT | American Bioproducts Co. | 1997-06-26 | 213 | 0 |
| K964728 | STA-LIATEST D-DI TEST KIT | American Bioproducts Co. | 1997-06-26 | 213 | 1 |
| K964718 | STA D-DI CALIBRATOR KIT | American Bioproducts Co. | 1997-05-23 | 179 | 0 |
| K962675 | STA - LIATEST VWF TEST KIT | American Bioproducts Co. | 1996-10-25 | 108 | 1 |
| K962671 | STA-VWF CALIBRATOR KIT | American Bioproducts Co. | 1996-09-13 | 66 | 0 |
| K962674 | STA - VWF CONTROL [N]+[P] KIT | American Bioproducts Co. | 1996-07-23 | 14 | 0 |
| K961579 | STA COMPACT AUTOMATED MULTI-PARAMETRIC ANALYZER | American Bioproducts Co. | 1996-07-10 | 77 | 3 |
| K955040 | AT-III CONTROL PLASMA KIT | American Bioproducts Co. | 1996-01-31 | 89 | 0 |
| K954040 | ASSERACHROM TOTAL PROTEIN S KIT | American Bioproducts Co. | 1995-11-13 | 77 | 0 |
| K954017 | ASSERACHROM FREE PROTEIN S KIT | American Bioproducts Co. | 1995-11-13 | 80 | 0 |
| K943520 | HEPARIN CONTROL KIT | American Bioproducts Co. | 1995-09-26 | 432 | 0 |
| K943514 | THE HEPANORM HBPM/LMWH KIT | American Bioproducts Co. | 1995-09-26 | 432 | 0 |
| K943519 | HBPM/LMWH CONTROL KIT | American Bioproducts Co. | 1995-09-26 | 432 | 0 |
| K952338 | STA-COAG CONTROL [P] PLUS KIT | American Bioproducts Co. | 1995-09-21 | 125 | 0 |
| K943515 | ROTACHROM HEPARIN TEST KIT | American Bioproducts Co. | 1995-08-31 | 406 | 0 |
| K943516 | ROTACHROM HBPM/LMWH TEST KIT | American Bioproducts Co. | 1995-08-31 | 406 | 0 |
| K925433 | THE STACHROM HEPARIN ASSAY KIT | American Bioproducts Co. | 1995-05-23 | 937 | 0 |
| K943517 | STACLOT HEPARIN TEST KIT | American Bioproducts Co. | 1995-05-11 | 294 | 0 |
| K944279 | AT-III CALIBRATOR | American Bioproducts Co. | 1995-04-07 | 220 | 0 |
| K943518 | STA SYSTEM CONTROL [N] + [P] KIT | American Bioproducts Co. | 1995-03-21 | 243 | 2 |
| K941210 | PTT-LT TEST KIT | American Bioproducts Co. | 1995-03-21 | 372 | 0 |
| K942117 | STA AUTOMATED MULTI-PARAMETRIC ANALYZER | American Bioproducts Co. | 1995-02-01 | 274 | 0 |
| K934606 | STAGO FACTOR II-DEFICIENT PLASMA | American Bioproducts Co. | 1994-03-01 | 155 | 0 |
| K934605 | STAGO FACTOR V-DEFICIENT PLASMA | American Bioproducts Co. | 1994-03-01 | 155 | 0 |
| K933432 | STAGO FACTOR IX-DEFICIENT PLASMA | American Bioproducts Co. | 1993-11-15 | 124 | 0 |
| K931906 | NEW STACHROM PROTEIN C TEST KIT | American Bioproducts Co. | 1993-11-05 | 206 | 0 |
| K933444 | STAGO FACTOR XI-DEFICIENT PLASMA | American Bioproducts Co. | 1993-10-27 | 105 | 0 |
| K933441 | STAGO FACTOR X-DEFICIENT PLASMA | American Bioproducts Co. | 1993-10-27 | 105 | 0 |
| K933438 | STAGO FACTOR XII-DEFICIENT PLASMA | American Bioproducts Co. | 1993-10-27 | 105 | 0 |
| K933440 | STAGO FACTOR VII-DEFICIENT PLASMA | American Bioproducts Co. | 1993-10-27 | 105 | 0 |
| K924370 | STACLOT(R) PNP TEST KIT | American Bioproducts Co. | 1993-08-09 | 346 | 0 |
| K930959 | FACTOR CONTROL [P] | American Bioproducts Co. | 1993-05-20 | 85 | 0 |
| K930923 | COAG-CONTROL | American Bioproducts Co. | 1993-04-27 | 63 | 0 |
| K923731 | STACLOT LA TEST KIT | American Bioproducts Co. | 1992-12-23 | 149 | 1 |
| K922565 | NEOPLASTINE(R) CI KIT | American Bioproducts Co. | 1992-12-07 | 189 | 0 |
| K922174 | COAG-CONTROL [N] KIT | American Bioproducts Co. | 1992-10-26 | 171 | 0 |
| K921449 | NEW STACHROM ANTIPLASMIN | American Bioproducts Co. | 1992-09-23 | 181 | 0 |
| K920943 | FDP PLASMA TEST KIT | American Bioproducts Co. | 1992-07-13 | 137 | 0 |
| K922040 | NEOPLASTINE CI PLUS | American Bioproducts Co. | 1992-06-23 | 53 | 1 |
| K921344 | THROMBO-CALIBRATOR KIT | American Bioproducts Co. | 1992-06-09 | 82 | 0 |
| K921665 | AVK CONTROL I & II | American Bioproducts Co. | 1992-06-09 | 63 | 0 |
| K921684 | PTT-LA TEST KIT | American Bioproducts Co. | 1992-06-09 | 62 | 1 |
| K922021 | UNICALIBRATOR KIT | American Bioproducts Co. | 1992-06-09 | 40 | 1 |
| K913424 | STACLOT(R) PROTEIN S TEST KIT | American Bioproducts Co. | 1991-10-08 | 68 | 0 |
| K912468 | LIATEST PROTEIN S KIT | American Bioproducts Co. | 1991-10-02 | 120 | 1 |
| K905110 | LIATEST(R) AT III TEST KIT | American Bioproducts Co. | 1991-01-24 | 72 | 0 |
| K904297 | ST-4 COAGULATION INSTRUMENT | American Bioproducts Co. | 1990-11-13 | 55 | 0 |
| K892859 | THE STAGO VIII DEFICIENT PLASMA KIT | American Bioproducts Co. | 1989-06-23 | 66 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda