510(k) K022118 ยท JHX Fluorometric Method, Cpk Or Isoenzymes
IMMULITE TURBO CK-MB, MODELS LSKCP1 (100 TESTS), LSKCP5 (500 TESTS)
| Applicant | Diagnostic Products Corp., Los Angeles CA, US |
| Decision | Substantially Equivalent, Jul 22, 2002 |
| Received | Jul 1, 2002 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K022118
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 21, 2012 | Siemens Healthcare Diagnostics IMMULITE/IMMULITE Turbo 1000 CK-MB LSKCP --- Catalog number: LSKCP1 (100 tests), LSKCP5 (500 tests) --- Test code: RCK Color: Orange.
For in vitro diagnostic use with the IMMULITE and IMMULITE 1000 A Terminated |
JHX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.