# K982209: Accuclot Thrombin Time Reagent Model A8713/A4589

- Pathway: 510(k) (Traditional)
- Applicant: Sigma Diagnostics, Inc.
- Decided: Oct 15, 1998 after 114 days
- Product code: GJA (Test, Thrombin Time)
- Device class: 2
- Regulation: 21 CFR 864.7875
- 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) Organon’s Thromboquik™ Thrombin Time Reagent: named in the summary without a submission number

## Indications for use
Sigma Diagnostics ACCUCLOT™ Thrombin Time Reagent (A8713/A4589) is a device intended to measure fibrinogen concentration and to detect fibrin or fibrinogen split products for the evaluation of bleeding disorders.

Source page: https://510kreport.com/device/K982209
Methodology: https://510kreport.com/methodology