510(k) K013628 ยท MSV System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi)
DIAMEDIX IS-ANTI-B2 GLYCOPROTEIN I IGG/IGM TEST SYSTEM
| Applicant | Diamedix Corp., Miami FL, US |
| Decision | Substantially Equivalent, Dec 21, 2001 |
| Received | Nov 5, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K013628
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.