JJYClass I

Multi-Analyte Controls, All Kinds (Assayed)

21 CFR 862.1660 / Clinical Chemistry

JJY is the FDA product code for Multi-Analyte Controls, All Kinds (Assayed), a class I device type, regulated under 21 CFR 862.1660. As of 2026-09-10, FDA records hold 673 510(k) clearances under this code, the most recent dated 2017-03-31, and 91 recalls.

Classification record

Product code: JJY
Device name: Multi-Analyte Controls, All Kinds (Assayed)
Regulation: 21 CFR 862.1660
Device class: Class I
Review panel: Clinical Chemistry
Submission type: 510(k) exempt
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 673
Ingested recalls: 91

Clearances, product code JJY

By decision year

673 clearances under product code JJY with a decision year between 1976 and 2017, 1990 the highest year at 38.

Show the numbers

510(k) clearances under FDA product code JJY by decision year
Year	Clearances
1976	1
1977	4
1978	5
1979	15
1980	10
1981	19
1982	11
1983	8
1984	11
1985	18
1986	30
1987	18
1988	26
1989	15
1990	38
1991	17
1992	20
1993	19
1994	20
1995	23
1996	24
1997	31
1998	27
1999	35
2000	14
2001	23
2002	20
2003	26
2004	25
2005	12
2006	11
2007	11
2008	7
2009	8
2010	10
2011	14
2012	13
2013	16
2014	10
2015	4
2016	1
2017	3

Applicants with the most clearances

Product code JJY

Applicants holding the most 510(k) clearances under product code JJY
Applicant	Clearances
Bio-Rad	61
Medical Analysis Systems, Inc.	31
Bio-Rad Laboratories Inc.	26
Cliniqa Corporation	22
Roche Diagnostics GmbH	22
Aalto Scientific Ltd.	19
Siemens Healthcare Diagnostics Inc.	19
Maine Standards Co.	19
Boehringer Mannheim Corp.	17
Casco Standards	15

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 104 companies shown, in name order