# K955724: KC 1A Coagulation Analyzer/Set

- Pathway: 510(k) (Traditional)
- Applicant: Sigma Diagnostics, Inc.
- Decided: Mar 12, 1996 after 85 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
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. The FDA summary names its predicate without a number.
- (no number) Fibrometer: named in the summary without a submission number
- (no number) CA-5000: named in the summary without a submission number

## Indications for use
The Amelung KC 1 A Micro Coagulation Analyzer is a semi-automated mechanical clot detection system designed for the determination of prothrombin times (PT), activated partial thromboplastin times (APTT), fibrinogen concentrations and other clotting tests. Any clotting time test that has fibrin formation as its endpoint may be performed on the KC 1 A.

Source page: https://510kreport.com/device/K955724
Methodology: https://510kreport.com/methodology