# K960875: KC 40 Micro Coagulation Analyzer System (K3632)

- Pathway: 510(k) (Traditional)
- Applicant: Sigma Diagnostics, Inc.
- Decided: Sep 10, 1996 after 190 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) TOA Medical Electronics CA-5000: named in the summary without a submission number
- (no number) BBL Fibrometer: named in the summary without a submission number

## Indications for use
The Amelung KC 40 Micro Coagulation Analyzer is an automated random access multipurpose analyzer. The KC 40 can be used for the detection of fibrin formation utilizing mechanical principles (ball method) to perform clot based tests such as prothrombin time (PT), activated partial thromboplastin time (APTT), fibrinogen, factor assays, and other clotting tests.

Source page: https://510kreport.com/device/K960875
Methodology: https://510kreport.com/methodology