Bartels Prognostics, Inc.: FDA clearances and approvals
Bartels Prognostics, Inc. has 0 FDA 510(k) clearances, plus 1 PMA decision, across 1 product code in 1 review panel.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MHR | Test, Anti-Tumor Cell Susceptibility | 1 | 0 |
Review panels
- Microbiology (1)
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P940036 | PMA | BARTELS CHEMORESPONSE ASSAY | 1996-08-01 |
Recalls
openFDA lists no recalls under a recalling firm named Bartels Prognostics, Inc..
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 Bartels Prognostics, Inc. have?
Bartels Prognostics, Inc. has 0 FDA 510(k) clearances, plus 1 PMA decision, across 1 product code in 1 review panel.
What devices does Bartels Prognostics, Inc. make?
Its most frequent FDA product codes are MHR (Test, Anti-Tumor Cell Susceptibility, 1).
Has Bartels Prognostics, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Bartels Prognostics, Inc. Related entities may recall under other names.
Next steps
- See all 0 Bartels Prognostics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code MHR, Bartels Prognostics, Inc.'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.