510(k) K854991 ยท GTQ Antistreptolysin - Titer/Streptolysin O Reagent
REUMAGEN ASL
| Applicant | Biokit USA, Inc., Barcelona, ES |
| Decision | Substantially Equivalent, Apr 18, 1986 |
| Received | Dec 12, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K854991
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.