510(k) K004002 ยท JHX Fluorometric Method, Cpk Or Isoenzymes
IMMULITE CK-MB, MODEL LKMB1 (100 TESTS), LKMB5 (500 TESTS); IMMULITE 2000 CK-MB, MODEL L2KMB2 (200 TESTS), L2KMB6 (600)
| Applicant | Diagnostic Products Corp., Los Angeles CA, US |
| Decision | Substantially Equivalent, Feb 14, 2001 |
| Received | Dec 26, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K004002
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 21, 2012 | Siemens Healthcare Diagnostics IMMULITE/IMMULITE 1000 CK-MB LKMB --- Catalog number: LKMB1 (100 tests), LKMB5 (500 tests) --- Test code: CMB Color: Dark Blue.
For in vitro diagnostic use with the IMMULITE and IMMULITE 1000 Analyze Terminated |
JHX | None listed |
| Mar 21, 2012 | Siemens Healthcare Diagnostics IMMULITE 2000/IMMULITE 2000 XPi CK-MB L2KMB --- Catalog number: L2KMB2 (200 tests), L2KMB6 (600 tests) --- Test code: CMB Color: Dark Blue.
For in vitro diagnostic use with the IMMULITE 2000 Analyzer Terminated |
JHX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.