510(k) K904416 ยท GTQ Antistreptolysin - Titer/Streptolysin O Reagent
CROATEST (R) RHEUMATOID DIAGNOSTIC
| Applicant | Biotrax, Inc., Baltimore MD, US |
| Decision | Substantially Equivalent, Jun 24, 1991 |
| Received | Sep 27, 1990 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K904416
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.