510(k) K883012 ยท JJY Multi-Analyte Controls, All Kinds (Assayed)
A.QC CHEMISTRY CONTROL LEVEL 2
| Applicant | Arden Medical Systems, Inc., Roseville MN, US |
| Decision | Substantially Equivalent, Sep 9, 1988 |
| Received | Jul 19, 1988 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K883012
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.