DIFClass I

Drug Mixture Control Materials

21 CFR 862.3280 / Clinical Toxicology

DIF is the FDA product code for Drug Mixture Control Materials, a class I device type, regulated under 21 CFR 862.3280. As of 2026-09-10, FDA records hold 202 510(k) clearances under this code, the most recent dated 2016-02-23, and 10 recalls.

Classification record

Product code: DIF
Device name: Drug Mixture Control Materials
Regulation: 21 CFR 862.3280
Device class: Class I
Review panel: Clinical Toxicology
Submission type: 510(k) exempt
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 202
Ingested recalls: 10

Clearances, product code DIF

By decision year

202 clearances under product code DIF with a decision year between 1978 and 2016, 1980 the highest year at 14.

Show the numbers

510(k) clearances under FDA product code DIF by decision year
Year	Clearances
1978	1
1979	1
1980	14
1981	11
1982	8
1983	12
1984	9
1985	4
1986	5
1987	7
1988	12
1989	7
1990	7
1991	10
1992	2
1993	6
1994	13
1995	12
1996	5
1997	9
1998	9
1999	2
2001	5
2002	5
2003	3
2004	5
2005	3
2006	4
2007	1
2008	2
2010	1
2011	1
2012	3
2013	2
2016	1

Applicants with the most clearances

Product code DIF

Applicants holding the most 510(k) clearances under product code DIF
Applicant	Clearances
Bio-Rad	31
Roche Diagnostic Systems, Inc.	14
Medical Analysis Systems, Inc.	13
Utak Laboratories Inc	13
Syva Co.	7
Bio-Rad Laboratories Inc.	5
Quantimetrix Corp.	5
Biosite Incorporated	4
Fisher Scientific Company L.L.C.	4
Syva Co.	4

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 29 companies shown, in name order