JJTClass I

Enzyme Controls (Assayed And Unassayed)

21 CFR 862.1660 / Clinical Chemistry

JJT is the FDA product code for Enzyme Controls (Assayed And Unassayed), a class I device type, regulated under 21 CFR 862.1660. As of 2026-09-10, FDA records hold 97 510(k) clearances under this code, the most recent dated 2009-12-14, and 2 recalls.

Classification record

Product code: JJT
Device name: Enzyme 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: 97
Ingested recalls: 2

Clearances, product code JJT

By decision year

97 clearances under product code JJT with a decision year between 1977 and 2009, 1977 the highest year at 9.

Show the numbers

510(k) clearances under FDA product code JJT by decision year
Year	Clearances
1977	9
1978	5
1979	4
1980	1
1981	4
1982	5
1984	3
1985	5
1986	6
1987	4
1988	5
1989	2
1990	3
1991	1
1992	1
1993	4
1994	5
1995	5
1996	3
1997	9
1998	3
1999	4
2001	1
2002	1
2003	2
2006	1
2009	1

Applicants with the most clearances

Product code JJT

Applicants holding the most 510(k) clearances under product code JJT
Applicant	Clearances
Beckman Instruments, Inc.	7
Bio-Rad	6
Cala Diagnostics	6
Dade, Baxter Travenol Diagnostics, Inc.	4
Helena Laboratories, Corp.	4
Clinical Controls, Inc.	3
Medical Analysis Systems, Inc.	3
Nyegaard & Co. A/S	3
Quantimetrix Corp.	3
Specialized Assays, Inc.	3

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 15 companies shown, in name order