510(k) K012243 ยท JJY Multi-Analyte Controls, All Kinds (Assayed)
MCC URICHECK ASSAYED LIQUID URINE MULTICONSTITUENT CONTROL
| Applicant | Hematronix, Inc., Benicia CA, US |
| Decision | Substantially Equivalent, Aug 20, 2001 |
| Received | Jul 17, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K012243
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.