# K931206: Electra 1600C Automatic Coagulation Timer

- Pathway: 510(k) (Traditional)
- Applicant: Medical Laboratory Automation Systems, Inc.
- Decided: Aug 23, 1993 after 166 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
No predicates in its family tree.
3 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K023362: Fisher Diagnostics Thromboscreen 1000; Pacific Hemostasis Fibrinogen Reagent Plus Kaolin (2002), 1 descendant of its own
- K060968: Stasis - I, II and Iii; Serathan - a, B; Intrin - EA, SI Calcium Chloride 0.02M; Fibrinogen Control-Normal, Low (2007), 0 descendants of its own
- K962664: Electra 1800C Automatic Coagulation Analyzer (1996), 0 descendants of its own

Source page: https://510kreport.com/device/K931206
Methodology: https://510kreport.com/methodology