# K083175: Berichrom Heparin UF Calibrator, Berichrom Heparin UF Control 1, and Berichrom Heparin UF Control 2

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Healthcare Diagnostics
- Decided: Jan 26, 2009 after 90 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 K812424 (1981). 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)
- K042941: Dade Behring Heparin Calibrator and Controls, Dade Behring, Inc. (2004) Summary page 2.

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

Source page: https://510kreport.com/device/K083175
Methodology: https://510kreport.com/methodology