510(k) K904311 ยท GTQ Antistreptolysin - Titer/Streptolysin O Reagent
RHEUMAGEN ASO T-CONTROL
| Applicant | Biokit USA, Inc., Barcelona, ES |
| Decision | Substantially Equivalent, Jan 25, 1991 |
| Received | Sep 19, 1990 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K904311
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.