510(k) K964640 ยท JJY Multi-Analyte Controls, All Kinds (Assayed)
CANTROL IRON/TIBC CONTROLS, LEVEL 1 AND LEVEL 2 PRODUCT NUMBERS: LEVEL 1: IIBC-91 AND LEVEL 2: IIBC-92
| Applicant | Canyon Diagnostics, Inc., Anaheim CA, US |
| Decision | Substantially Equivalent, Dec 13, 1996 |
| Received | Nov 19, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K964640
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.