JJSClass I

Controls For Blood-Gases, (Assayed And Unassayed)

21 CFR 862.1660 / Clinical Chemistry

JJS is the FDA product code for Controls For Blood-Gases, (Assayed And Unassayed), a class I device type, regulated under 21 CFR 862.1660. As of 2026-09-10, FDA records hold 67 510(k) clearances under this code, the most recent dated 2016-04-22, and one recall.

Classification record

Product code: JJS
Device name: Controls For Blood-Gases, (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: 67
Ingested recalls: 1

Clearances, product code JJS

By decision year

67 clearances under product code JJS with a decision year between 1977 and 2016, 2000 the highest year at 7.

Show the numbers

510(k) clearances under FDA product code JJS by decision year
Year	Clearances
1977	4
1978	2
1979	6
1980	1
1981	5
1982	4
1983	4
1984	1
1985	1
1986	1
1987	3
1989	1
1990	4
1992	4
1994	1
1995	6
1996	3
1997	1
1998	1
2000	7
2002	2
2003	1
2013	2
2015	1
2016	1

Applicants with the most clearances

Product code JJS

Applicants holding the most 510(k) clearances under product code JJS
Applicant	Clearances
Bio-Rad	9
Radiometer America, Inc	9
Bionostics, Inc.	5
Phoenix Diagnostics, Inc.	5
American Dade	3
Analytical Products, Inc.	3
Corning Medical & Scientific	3
Instrumentation Laboratory Co.	3
Radiometer Medical ApS	3
Ciba Corning Diagnostics Corp.	2

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 15 companies shown, in name order