JJWClass I

Urinalysis Controls (Assayed And Unassayed)

21 CFR 862.1660 / Clinical Chemistry

JJW is the FDA product code for Urinalysis Controls (Assayed And Unassayed), a class I device type, regulated under 21 CFR 862.1660. As of 2026-09-10, FDA records hold 61 510(k) clearances under this code, the most recent dated 2017-02-09, and 22 recalls.

Classification record

Product code: JJW
Device name: Urinalysis Controls (Assayed And Unassayed)
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: 61
Ingested recalls: 22

Clearances, product code JJW

By decision year

61 clearances under product code JJW with a decision year between 1976 and 2017, 1983 the highest year at 4.

Show the numbers

510(k) clearances under FDA product code JJW by decision year
Year	Clearances
1976	1
1977	2
1978	3
1979	3
1981	1
1982	1
1983	4
1984	4
1985	2
1986	2
1988	4
1989	3
1990	1
1993	2
1994	3
1995	2
1997	2
1998	1
1999	3
2000	1
2002	3
2003	2
2004	1
2005	2
2007	2
2009	1
2011	2
2014	1
2015	1
2017	1

Applicants with the most clearances

Product code JJW

Applicants holding the most 510(k) clearances under product code JJW
Applicant	Clearances
Medical Analysis Systems, Inc.	6
Bio-Rad	5
Helena Laboratories, Corp.	3
Icl Scientific	3
Miles Laboratories, Inc.	3
Consolidated Technologies, Inc.	2
Environmental Chemical Specialties	2
Kulzer GmbH	2
International Remote Imaging Systems	2
Kenlor Industries, Inc.	2

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 33 companies shown, in name order