JTOClass I

Discs, Strips And Reagents, Microorganism Differentiation

21 CFR 866.2660 / Microbiology

JTO is the FDA product code for Discs, Strips And Reagents, Microorganism Differentiation, a class I device type, regulated under 21 CFR 866.2660. As of 2026-09-10, FDA records hold 244 510(k) clearances under this code, the most recent dated 2005-09-01, and 21 recalls.

Classification record

Product code: JTO
Device name: Discs, Strips And Reagents, Microorganism Differentiation
Regulation: 21 CFR 866.2660
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: 244
Ingested recalls: 21

Clearances, product code JTO

By decision year

244 clearances under product code JTO with a decision year between 1976 and 2005, 1984 the highest year at 47.

Show the numbers

510(k) clearances under FDA product code JTO by decision year
Year	Clearances
1976	1
1977	1
1978	1
1979	2
1980	15
1981	15
1982	19
1983	22
1984	47
1985	11
1986	18
1987	12
1988	3
1989	5
1990	5
1991	15
1992	7
1993	15
1994	12
1995	8
1996	5
1997	4
2005	1

Applicants with the most clearances

Product code JTO

Applicants holding the most 510(k) clearances under product code JTO
Applicant	Clearances
Difco Laboratories, Inc.	34
Remel Inc	33
Remel Co.	16
Dms Laboratories	13
Austin Biological Laboratories	12
E-Y Laboratories, Inc.	11
Oxoid U.S.A., Inc.	11
Carr-Scarborough Microbiologicals, Inc.	10
Hardy Diagnostics	10
Microbiologics, Inc.	9

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 27 companies shown, in name order