510(k) K944513 ยท JJY Multi-Analyte Controls, All Kinds (Assayed)
LINICAL PROTEIN VI CALIBRATION VERIFIERS LEVELS A-E
| Applicant | International Enzymes, Inc., Fallbrook CA, US |
| Decision | Substantially Equivalent, Dec 2, 1994 |
| Received | Sep 15, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K944513
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.