510(k) K040535 ยท JJY Multi-Analyte Controls, All Kinds (Assayed)
LINICAL ENZYME CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER SYNCHRON SYSTEMS
| Applicant | Cliniqa Corporation, Fallbrook CA, US |
| Decision | Substantially Equivalent, Mar 29, 2004 |
| Received | Mar 2, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K040535
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.