510(k) K894486 ยท GTQ Antistreptolysin - Titer/Streptolysin O Reagent
QUANTEX ASO PLUS (LATEX,BUFFER STANDARD,CONTROL)
| Applicant | Biokit USA, Inc., Barcelona, ES |
| Decision | Substantially Equivalent, Oct 24, 1989 |
| Received | Jul 18, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K894486
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.