510(k) K981099 ยท JHX Fluorometric Method, Cpk Or Isoenzymes
STRATUS CS STAT FLUOROMETRIC ANALYZER AND STRATUS CS CKMB TESTPAK
| Applicant | Dade Behring, Inc., Newark DE, US |
| Decision | Substantially Equivalent, May 26, 1998 |
| Received | Mar 26, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K981099
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 19, 2006 | Dade Behring , Inc. Stratus CS STAT Fluorometric Analyzer CKMB DilPak (CCKMB-D) in vitro diagnostic. Terminated |
JHX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.