510(k) K034055 ยท JHX Fluorometric Method, Cpk Or Isoenzymes
IMMULITE 2500 CK-MB, 2500 MYOGLOBIN, 2500 STAT TROPONIN I
| Applicant | Diagnostic Products Corp., Los Angeles CA, US |
| Decision | Substantially Equivalent, Jan 21, 2004 |
| Received | Dec 30, 2003 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K034055
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 21, 2012 | Siemens Healthcare Diagnostics IMMULITE 2500 CK-MB L5KCP --- Catalog number: L5KCP2 (200 tests), L5KCP6 (600 tests) --- Test code: RCK Color: Orange.
For in vitro diagnostic use with the IMMULITE 2500 Analyzer --- for the quantita Terminated |
JHX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.