510(k) K043007 ยท JBQ Antithrombin Iii Quantitation
BIOPHEN ANTITHROMBIN 2.5, REFERENCE # 221102; BIOPHEN ANTITHROMBIN 5, REFERENCE # 221105
| Applicant | Hyphen Biomed, Mason OH, US |
| Decision | Substantially Equivalent, Nov 7, 2005 |
| Received | Nov 1, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K043007
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.