# K083159: Berichrom Heparin LMW Calibrator, Berichrom Heparin LMW Control 1, and Berichrom Heparin LMW Control 2

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Healthcare Diagnostics
- Decided: Jan 26, 2009 after 91 days
- Product code: JPA (System, Multipurpose For In Vitro Coagulation Studies)
- Device class: 2
- Regulation: 21 CFR 864.5425
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K002400 (2000). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030964: Calibration Plasma LMW Heparin, Instrumentation Laboratory CO (2003) Summary page 2.
- K030965: Control Plasma LMW Heparin, Instrumentation Laboratory CO (2003) Summary page 2.

## Indications for use
Benchrom Heparin LMW Calibrator is an in vitro diagnostic product used for the calibration of the Benchrom Heparin assay for measurement of low molecular weight (LMW) heparin Benchrom Heparin LMW Control 1 is an assayed, low level, quality control material for assessment of precision and analytical bias in the quantitative determination of low molecular weight (LMW) heparin with the Berichrom Heparin assay Berichrom Heparin LMW Control 2 is an assayed, high level, quality control material for assessment of precision and analytical bias in the quantitative determination of low molecular weight (LMW) heparin with the Berichrom Heparin assay

Source page: https://510kreport.com/device/K083159
Methodology: https://510kreport.com/methodology