GJSClass II

Test, Time, Prothrombin

21 CFR 864.7750 / Hematology

GJS is the FDA product code for Test, Time, Prothrombin, a class II device type, regulated under 21 CFR 864.7750. As of 2026-09-10, FDA records hold 127 510(k) clearances under this code, the most recent dated 2025-10-24, and 73 recalls.

Classification record

Product code: GJS
Device name: Test, Time, Prothrombin
Regulation: 21 CFR 864.7750
Device class: Class II
Review panel: Hematology
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 127
Ingested recalls: 73

Clearances, product code GJS

By decision year

127 clearances under product code GJS with a decision year between 1978 and 2025, 2002 the highest year at 8.

Show the numbers

510(k) clearances under FDA product code GJS by decision year
Year	Clearances
1978	1
1979	3
1981	2
1983	2
1984	2
1985	2
1986	5
1987	4
1988	6
1989	7
1990	5
1991	7
1992	4
1993	5
1994	5
1995	6
1996	3
1997	3
1998	4
1999	3
2000	2
2001	4
2002	8
2003	1
2004	2
2005	1
2006	2
2007	4
2008	1
2010	4
2012	1
2013	1
2014	1
2016	1
2017	1
2018	2
2019	2
2020	1
2022	3
2023	2
2024	1
2025	3

Applicants with the most clearances

Product code GJS

Applicants holding the most 510(k) clearances under product code GJS
Applicant	Clearances
Roche Diagnostics GmbH	14
Instrumentation Laboratory Co.	11
Accriva Diagnostics, Inc.	8
Helena Laboratories, Corp.	6
Iline Microsystems S.L.	5
bioMerieux, Inc.	5
Pacific Hemostasis	5
Analytical Control Systems	4
Cardiovascular Diagnostic Services	4
American Bioproducts Co.	3

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 31 companies shown, in name order