510(k) K910885 ยท GTQ Antistreptolysin - Titer/Streptolysin O Reagent
QM300 CALIBRATOR G PACK
| Applicant | Kallestad Diag, A Div. of Erbamont, Inc., Chaska MN, US |
| Decision | Substantially Equivalent, Jun 17, 1991 |
| Received | Mar 4, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K910885
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.