Bd Diagnostics: FDA clearances and approvals
Bd Diagnostics has 0 FDA 510(k) clearances, plus 2 PMA decisions, across 1 product code in 1 review panel.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MNM | Reader, Cervical Cytology Slide, Automated | 2 | 0 |
Review panels
- Pathology (2)
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P940029 | PMA | PAPNET (R) TESTING SYSTEM | 1995-11-08 |
| P950009 | PMA | AUTOPAP(R) 300 QC AUTOMATIC PAP SCREENER/QC SYSTEM | 1995-09-29 |
Recalls
openFDA lists no recalls under a recalling firm named Bd Diagnostics.
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 Bd Diagnostics have?
Bd Diagnostics has 0 FDA 510(k) clearances, plus 2 PMA decisions, across 1 product code in 1 review panel.
What devices does Bd Diagnostics make?
Its most frequent FDA product codes are MNM (Reader, Cervical Cytology Slide, Automated, 2).
Has Bd Diagnostics had device recalls?
openFDA lists no recalls under a recalling firm name matching Bd Diagnostics. Related entities may recall under other names.
Next steps
- See all 0 Bd Diagnostics clearances with predicates and recalls
- Run predicate analysis for product code MNM, Bd Diagnostics'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.