510(k) K011389 ยท JCM Control, Hemoglobin, Abnormal
HEMOGLOBIN F & A2 CONTROL (BETA-THALASSAEMIA CONTROL)
| Applicant | Canterbury Health Laboratories, Christchurch, Canterbury, NZ |
| Decision | Substantially Equivalent, Jun 21, 2001 |
| Received | May 7, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K011389
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.