JJFClass I

Analyzer, Chemistry, Micro, For Clinical Use

21 CFR 862.2170 / Clinical Chemistry

JJF is the FDA product code for Analyzer, Chemistry, Micro, For Clinical Use, a class I device type, regulated under 21 CFR 862.2170. As of 2026-09-10, FDA records hold 57 510(k) clearances under this code, the most recent dated 2006-03-31, and 13 recalls.

Classification record

Product code: JJF
Device name: Analyzer, Chemistry, Micro, For Clinical Use
Regulation: 21 CFR 862.2170
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: 57
Ingested recalls: 13

Clearances, product code JJF

By decision year

57 clearances under product code JJF with a decision year between 1977 and 2006, 1985 the highest year at 5.

Show the numbers

510(k) clearances under FDA product code JJF by decision year
Year	Clearances
1977	3
1978	2
1979	2
1980	4
1982	4
1983	4
1984	4
1985	5
1986	1
1987	5
1988	1
1989	3
1990	1
1991	1
1993	1
1994	1
1995	1
1996	1
1997	5
1998	2
1999	1
2002	2
2003	1
2004	1
2006	1

Applicants with the most clearances

Product code JJF

Applicants holding the most 510(k) clearances under product code JJF
Applicant	Clearances
Beckman Instruments, Inc.	3
Kone Instruments, Inc.	3
Syva Co.	3
Technicon Instruments Corp.	3
Alpkem Corp.	2
Associated Electro-Medical Services, Inc.	2
Hi Chem, Inc.	2
Instrumentation Laboratory Co.	2
Lkb Instruments, Inc.	2
Nova Biomedical Corporation	2

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 30 companies shown, in name order