510(k) K984065 ยท DDR Myoglobin, Antigen, Antiserum, Control
STRATUS (R) CS MYOGLOBIN (MYO) TESTPAK
| Applicant | Dade Behring, Inc., Newark DE, US |
| Decision | Substantially Equivalent, Dec 14, 1998 |
| Received | Nov 16, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K984065
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 19, 2006 | Dade Behring , Inc. Stratus CS STAT Fluorometric Analyzer MYO TestPak (CMYO) in vitro diagnostic. Terminated |
DDR | None listed |
| May 19, 2006 | Dade Behring , Inc. Stratus CS STAT Fluorometric Analyzer MYO DilPak (CMYO-D) in vitro diagnostic. Terminated |
DDR | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.