510(k) K013995 ยท JJY Multi-Analyte Controls, All Kinds (Assayed)
MODIFICATION TO MAS CARDIOLMMUNE TL; DADE CARDIAC TL
| Applicant | Medical Analysis Systems, Inc., Camarillo CA, US |
| Decision | Substantially Equivalent, Dec 21, 2001 |
| Received | Dec 4, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K013995
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.