510(k) K922856 ยท CIG Diazo Colorimetry, Bilirubin
SYSTEMATE DIRECT BILIRUBIN TEST TECHNICON RA 1000
| Applicant | Em Diagnostic Systems, Inc., Gibbstown NJ, US |
| Decision | Substantially Equivalent, Sep 9, 1992 |
| Received | Jun 15, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K922856
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.