510(k) K955355 ยท GKA Abnormal Hemoglobin Quantitation
VARIANT ALPHA-THALASSEMIA SHORT PROGRAM
| Applicant | Bio-Rad, Hercules CA, US |
| Decision | Substantially Equivalent, Apr 26, 1996 |
| Received | Nov 21, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K955355
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.