JTO · Class I · 21 CFR 866.2660

FDA Product Code JTO: Discs, Strips And Reagents, Microorganism Differentiation

Leading manufacturers include Remel Co., Difco Laboratories, Inc. and Dms Laboratories.

244
Total
244
Cleared
59d
Avg days
1976
Since
244 devices
49–72 of 244
Cleared Sep 19, 1991
BACTIDROP(TM) NITRATE A
K913011
Remel Co.
Microbiology · 73d
Cleared Sep 18, 1991
BACTIDROP(TM) DESOXYCHOLATE (10%)
K913001
Remel Co.
Microbiology · 72d
Cleared Sep 18, 1991
BACTIDROP(TM) SPOT INDOLE
K913004
Remel Co.
Microbiology · 72d
Cleared Sep 18, 1991
BACTIDROP(TM) INDOLE (KOVACS)
K913009
Remel Co.
Microbiology · 72d
Cleared Aug 23, 1991
BBL(R) DMACA INDOLE REAGENT DROPPERS
K912480
Bd Becton Dickinson Vacutainer Systems Preanalytic
Microbiology · 81d
Cleared Feb 27, 1991
LAP DISCS
K905472
Carr-Scarborough Microbiologicals, Inc.
Microbiology · 83d
Cleared Feb 26, 1991
M. CAT. BUTYRATE DISC
K905666
Carr-Scarborough Microbiologicals, Inc.
Microbiology · 70d
Cleared Feb 20, 1991
NITRATE DISK
K905163
Remel Co.
Microbiology · 96d
Cleared Jan 25, 1991
VANCOMYCIN DISK-5 MCG
K905151
Remel Co.
Microbiology · 71d
Cleared Oct 02, 1990
CATARRHALIS TEST STRIP
K902595
Remel Co.
Microbiology · 112d
Cleared Jun 20, 1990
DRYSLIDE, BETA-LACTAMASE
K901784
Difco Laboratories, Inc.
Microbiology · 64d
Cleared Jun 01, 1990
PATHODX PYR KIT
K902037
Diagnostic Products Corp.
Microbiology · 28d
Cleared Apr 16, 1990
DMAC INDOLE REAGENT
K901390
Analytical Products, Inc.
Microbiology · 21d
Cleared Dec 18, 1989
DIFCO OXIDASE DRYSLIDE
K896398
Difco Laboratories, Inc.
Microbiology · 42d
Cleared Sep 28, 1989
ROSCO PYRR
K894221
Pro-Lab, Inc.
Microbiology · 101d
Cleared Feb 16, 1989
PRO DISCS
K882630
Carr-Scarborough Microbiologicals, Inc.
Microbiology · 234d
Cleared Feb 16, 1989
ALN DISCS
K882636
Carr-Scarborough Microbiologicals, Inc.
Microbiology · 234d
Cleared Apr 01, 1988
PYR/ESCULIN DISK
K880950
Remel Co.
Microbiology · 25d
Cleared May 28, 1987
LD PRESUMPTO QUAD
K871907
Bd Becton Dickinson Vacutainer Systems Preanalytic
Microbiology · 13d
Cleared Apr 21, 1987
GEN-PROBE BETA-LACTAMASE TEST KIT
K870422
Gen-Probe, Inc.
Microbiology · 77d
Cleared Apr 03, 1987
SPOTTEST 10% SODIUM DESOXYCHOLATE
K870716
Difco Laboratories, Inc.
Microbiology · 42d
Cleared Apr 03, 1987
SPOTTEST MICRODASE
K870717
Difco Laboratories, Inc.
Microbiology · 42d
Cleared Mar 31, 1987
GARNERELLA VAGINALIS IDENTIFICATION KIT
K864244
Mds Laboratories, Inc.
Microbiology · 154d
Cleared Feb 26, 1987
SPOTTEST PYR REAGENT
K870449
Difco Laboratories, Inc.
Microbiology · 23d