American Bioproducts Co.: FDA clearances and approvals
American Bioproducts Co. has 79 FDA 510(k) clearances (first 1985, latest 1998), across 21 product codes in 3 review panels. Median 510(k) review time: 97 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GGP | Test, Qualitative And Quantitative Factor Deficiency | 22 | 22 |
| GJT | Plasma, Coagulation Factor Deficient | 9 | 9 |
| KFF | Assay, Heparin | 8 | 8 |
| GGC | Control, Plasma, Abnormal | 5 | 5 |
| GGN | Plasma, Coagulation Control | 5 | 5 |
| DAP | Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control | 4 | 4 |
| GGW | Test, Time, Partial Thromboplastin | 4 | 4 |
| GHH | Fibrin Split Products | 3 | 3 |
| GJS | Test, Time, Prothrombin | 3 | 3 |
| GKP | Instrument, Coagulation, Automated | 3 | 3 |
Plus 11 more product codes.
Review panels
- Hematology (76)
- Clinical Chemistry (1)
- Immunology (1)
Most recent American Bioproducts Co. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K983460 | STAR AUTOMATED MULTI-PARAMETRIC ANALYZER | JPA | 1998-11-12 | 43 |
| K971519 | ASSERACHROM TPA TEST KIT | GGP | 1997-08-19 | 116 |
| K964728 | STA-LIATEST D-DI TEST KIT | DAP | 1997-06-26 | 213 |
| K964716 | STA LIATEST CONTROL [N]+[P] KIT | GGN | 1997-06-26 | 213 |
| K964718 | STA D-DI CALIBRATOR KIT | DAP | 1997-05-23 | 179 |
| K962675 | STA - LIATEST VWF TEST KIT | GJT | 1996-10-25 | 108 |
| K962671 | STA-VWF CALIBRATOR KIT | GJT | 1996-09-13 | 66 |
| K962674 | STA - VWF CONTROL [N]+[P] KIT | GGN | 1996-07-23 | 14 |
| K961579 | STA COMPACT AUTOMATED MULTI-PARAMETRIC ANALYZER | GKP | 1996-07-10 | 77 |
| K955040 | AT-III CONTROL PLASMA KIT | GGC | 1996-01-31 | 89 |
69 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named American Bioproducts Co..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of American Bioproducts Co.'s product codes (a text match, not an official crosswalk):
- J7197 — Antithrombin iii (human), per i.u. (via JBQ)
- J7213 — Injection, coagulation factor ix (recombinant), ixinity, 1 i.u. (via GJT)
Frequently asked questions
How many FDA 510(k) clearances does American Bioproducts Co. have?
American Bioproducts Co. has 79 FDA 510(k) clearances (first 1985, latest 1998), across 21 product codes in 3 review panels.
How long does FDA take to clear American Bioproducts Co.'s 510(k)s?
The median time from FDA receipt to decision across American Bioproducts Co.'s cleared 510(k)s is 97 days.
What devices does American Bioproducts Co. make?
Its most frequent FDA product codes are GGP (Test, Qualitative And Quantitative Factor Deficiency, 22); GJT (Plasma, Coagulation Factor Deficient, 9); KFF (Assay, Heparin, 8).
Has American Bioproducts Co. had device recalls?
openFDA lists no recalls under a recalling firm name matching American Bioproducts Co. Related entities may recall under other names.
Next steps
- See all 79 American Bioproducts Co. clearances with predicates and recalls
- Run predicate analysis for product code GGP, American Bioproducts Co.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.