GGPClass II

Test, Qualitative And Quantitative Factor Deficiency

21 CFR 864.7290 / Hematology

GGP is the FDA product code for Test, Qualitative And Quantitative Factor Deficiency, a class II device type, regulated under 21 CFR 864.7290. As of 2026-09-10, FDA records hold 190 510(k) clearances under this code, the most recent dated 2025-08-25, and 14 recalls.

Classification record

Product code: GGP
Device name: Test, Qualitative And Quantitative Factor Deficiency
Regulation: 21 CFR 864.7290
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: Yes
Ingested clearances: 190
Ingested recalls: 14

Clearances, product code GGP

By decision year

190 clearances under product code GGP with a decision year between 1977 and 2025, 1984 the highest year at 16.

Show the numbers

510(k) clearances under FDA product code GGP by decision year
Year	Clearances
1977	1
1979	9
1980	2
1981	3
1982	3
1983	4
1984	16
1985	2
1986	11
1987	11
1988	7
1989	7
1990	8
1991	7
1992	7
1993	5
1994	3
1995	9
1996	12
1997	9
1998	9
1999	2
2000	6
2001	4
2002	3
2003	2
2004	4
2005	4
2006	3
2007	3
2008	2
2009	1
2011	1
2014	1
2018	1
2019	1
2020	2
2022	2
2023	2
2025	1

Applicants with the most clearances

Product code GGP

Applicants holding the most 510(k) clearances under product code GGP
Applicant	Clearances
Instrumentation Laboratory Co.	28
American Bioproducts Co.	22
Helena Laboratories, Corp.	17
American Dade	9
Biopool AB	9
Sigma Chemical Co.	9
Precision BioLogic Inc.	7
Baxter Healthcare Corporation	6
Behring Diagnostics, Inc.	5
Medical Diagnostic Technologies, Inc.	5

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 20 companies shown, in name order