Inverness Medical Professional Diagnostics-Binax: FDA clearances and approvals
Inverness Medical Professional Diagnostics-Binax has 0 FDA 510(k) clearances, plus 1 De Novo decision, across 1 product code in 1 review panel.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| OAX | Plasmodium Spp. Detection Reagents | 1 | 0 |
Review panels
- Microbiology (1)
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN070006 | De Novo | Plasmodium Spp. Detection Reagents | 2007-06-13 |
Recalls
openFDA lists no recalls under a recalling firm named Inverness Medical Professional Diagnostics-Binax.
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 Inverness Medical Professional Diagnostics-Binax have?
Inverness Medical Professional Diagnostics-Binax has 0 FDA 510(k) clearances, plus 1 De Novo decision, across 1 product code in 1 review panel.
What devices does Inverness Medical Professional Diagnostics-Binax make?
Its most frequent FDA product codes are OAX (Plasmodium Spp. Detection Reagents, 1).
Has Inverness Medical Professional Diagnostics-Binax had device recalls?
openFDA lists no recalls under a recalling firm name matching Inverness Medical Professional Diagnostics-Binax. Related entities may recall under other names.
Next steps
- See all 0 Inverness Medical Professional Diagnostics-Binax clearances with predicates and recalls
- Run predicate analysis for product code OAX, Inverness Medical Professional Diagnostics-Binax'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.