# K962664: Electra 1800C Automatic Coagulation Analyzer

- Pathway: 510(k) (Traditional)
- Applicant: Medical Laboratory Automation Systems, Inc.
- Decided: Sep 10, 1996 after 63 days
- Product code: GKP (Instrument, Coagulation, Automated)
- Device class: 2
- Regulation: 21 CFR 864.5400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K931206 (1993). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K931206: Electra 1600C Automatic Coagulation Timer, Medical Laboratory Automation Systems, Inc. (1993) Summary page 1.

## Indications for use
The ELECTRA 1800C is an in vitro diagnostic instrument which may be categorized as an automatic coagulation timer and photometric analyzer, for the performance of both coagulation and chromogenic testing. Coagulation testing capabilities of the proposed product include routine clotting tests such as prothrombin time (PT), activated partial thromboplastin time (APTT), factor assays, fibrinogen, and thrombin time. Chromogenic testing capabilities include tests such as Antithrombin I1I.

Source page: https://510kreport.com/device/K962664
Methodology: https://510kreport.com/methodology