Aerojet Medical and Biological Systems: FDA clearances and approvals
Aerojet Medical and Biological Systems has 0 FDA 510(k) clearances, plus 1 PMA decision, across 1 product code.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| N17578 | PMA | INDIRECT FLUORESCENT-ANTIBODY TEST FOR GONORRHEA (IFA-GC) | 1976-05-28 |
Recalls
openFDA lists no recalls under a recalling firm named Aerojet Medical and Biological Systems.
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.
Frequently asked questions
How many FDA 510(k) clearances does Aerojet Medical and Biological Systems have?
Aerojet Medical and Biological Systems has 0 FDA 510(k) clearances, plus 1 PMA decision, across 1 product code.
Has Aerojet Medical and Biological Systems had device recalls?
openFDA lists no recalls under a recalling firm name matching Aerojet Medical and Biological Systems. Related entities may recall under other names.
Next steps
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.