DAPClass II

Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control

21 CFR 864.7320 / Hematology

DAP is the FDA product code for Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control, a class II device type, regulated under 21 CFR 864.7320. As of 2026-09-10, FDA records hold 58 510(k) clearances under this code, the most recent dated 2026-08-11, and 13 recalls.

Classification record

Product code: DAP
Device name: Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
Regulation: 21 CFR 864.7320
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: 58
Ingested recalls: 13

Clearances, product code DAP

By decision year

58 clearances under product code DAP with a decision year between 1986 and 2026, 2001 the highest year at 7.

Show the numbers

510(k) clearances under FDA product code DAP by decision year
Year	Clearances
1986	1
1987	1
1988	1
1989	1
1991	1
1992	4
1993	1
1994	1
1995	1
1997	3
1998	3
2000	2
2001	7
2002	3
2003	4
2004	5
2005	3
2007	2
2008	3
2009	1
2010	2
2011	1
2012	1
2014	1
2015	1
2016	2
2017	1
2026	1

Applicants with the most clearances

Product code DAP

Applicants holding the most 510(k) clearances under product code DAP
Applicant	Clearances
Siemens Healthcare Diagnostics Inc.	10
Instrumentation Laboratory Co.	10
bioMerieux, Inc.	9
American Bioproducts Co.	4
Sigma Diagnostics, Inc.	4
Agen Biomedical, Ltd.	3
Biosite Incorporated	2
Diagnostica Stago, Inc.	2
Kamiya Biomedical Company, LLC	2
More Diagnostics Inc.	2

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 26 companies shown, in name order