510(k) K881438 ยท JJY Multi-Analyte Controls, All Kinds (Assayed)
UREA/GLUCOSE/CREATININE SERUM RANGE LINEARITY STAN
| Applicant | Hichem Diagnostics, Brea CA, US |
| Decision | Substantially Equivalent, Jul 6, 1988 |
| Received | Apr 5, 1988 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K881438
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.