# K004002: Immulite CK-MB, Model LKMB1 (100 Tests), LKMB5 (500 Tests); Immulite 2000 CK-MB, Model L2KMB2 (200 Tests), L2KMB6 (600)

- Pathway: 510(k) (Traditional)
- Applicant: Diagnostic Products Corp.
- Decided: Feb 14, 2001 after 50 days
- Product code: JHX (Fluorometric Method, Cpk Or Isoenzymes)
- Device class: 2
- Regulation: 21 CFR 862.1215
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K022118: Immulite Turbo CK-MB, Models LSKCP1 (100 Tests), LSKCP5 (500 Tests) (2002), 1 descendant of its own
- K034055: Immulite 2500 CK-MB, 2500 Myoglobin, 2500 Stat Troponin I (2004), 0 descendants of its own

## Recalls of this device
- Jan 25, 2012 · Not classified · Z-1273-2012: Siemens Healthcare Diagnostics has observed that the median for the reference range with current kit lots of the CK-MB assay differs from the guidelines published in the Instructions for Use (IFU). Th
- Jan 25, 2012 · Not classified · Z-1271-2012: Siemens Healthcare Diagnostics has observed that the median for the reference range with current kit lots of the CK-MB assay differs from the guidelines published in the Instructions for Use (IFU). Th

Source page: https://510kreport.com/device/K004002
Methodology: https://510kreport.com/methodology