510(k) K071648 ยท JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
EXTENDSURE LYOPHILIZED HBA1C LINEARITY CONTROLS
| Applicant | Canterbury Scientific , Ltd., Christchurch, NZ |
| Decision | Substantially Equivalent, Aug 22, 2007 |
| Received | Jun 18, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K071648
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.