# K132722: Hemosil Recombiplastin 2G (8 ML Vial)

- Pathway: 510(k) (Special)
- Applicant: Instrumentation Laboratory CO
- Decided: Jan 22, 2014 after 145 days
- Product code: GJS (Test, Time, Prothrombin)
- Device class: 2
- Regulation: 21 CFR 864.7750
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
HemosiLl RecombiPlasTin 2G is a high sensitivity thromboplastin reagent based on recombinant human tissue factor (RTF) for the quantitative determination in human citrated plasma of Prothmombin Time (PT) and Fibrinogen on IL Coagulation Systems. The product is used for the evaluation of the extrinsic coagulation pathway and the monitoring of Oral Anticoagulant Therapy (OAT).

Source page: https://510kreport.com/device/K132722
Methodology: https://510kreport.com/methodology