JSIClass I

Culture Media, Selective And Differential

21 CFR 866.2360 / Microbiology

JSI is the FDA product code for Culture Media, Selective And Differential, a class I device type, regulated under 21 CFR 866.2360. As of 2026-09-10, FDA records hold 285 510(k) clearances under this code, the most recent dated 2007-11-20, and 24 recalls.

Classification record

Product code: JSI
Device name: Culture Media, Selective And Differential
Regulation: 21 CFR 866.2360
Device class: Class I
Review panel: Microbiology
Submission type: 510(k) exempt
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 285
Ingested recalls: 24

Clearances, product code JSI

By decision year

285 clearances under product code JSI with a decision year between 1977 and 2007, 1981 the highest year at 48.

Show the numbers

510(k) clearances under FDA product code JSI by decision year
Year	Clearances
1977	1
1978	1
1979	26
1980	5
1981	48
1982	30
1983	28
1984	39
1985	35
1986	17
1987	40
1988	11
1989	2
1998	1
2007	1

Applicants with the most clearances

Product code JSI

Applicants holding the most 510(k) clearances under product code JSI
Applicant	Clearances
Neogen Culture Media	40
Otisville Biotech, Inc.	20
Hardy Media	17
Isle Media and Sterile Products, Inc.	15
Lakewood Biochemical Co., Inc.	14
Anaerobe Systems	12
Micro Media Laboratories	11
bioMerieux, Inc.	11
American Laboratory Supply, Inc.	10
Apl Medical Supplies	9

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 26 companies shown, in name order