510(k) K921477 ยท JJY Multi-Analyte Controls, All Kinds (Assayed)
I-STAT(TM) LEVELS 1,2,3 CONTROLS
| Applicant | I-Stat Corp., Ontario K2l 1t9, Canada, CA |
| Decision | Substantially Equivalent, Nov 2, 1992 |
| Received | Mar 30, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K921477
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.