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
121–144 of 244
Cleared Mar 09, 1984
AMS GRAM-POSITIVE IDENT. CARD
K834389
Vitek Systems, Inc.
Microbiology · 86d
Cleared Mar 02, 1984
DISCS
K840028
Anaerobe Systems
Microbiology · 57d
Cleared Mar 02, 1984
STRIPS
K840029
Anaerobe Systems
Microbiology · 57d
Cleared Mar 02, 1984
REAGENTS
K840030
Anaerobe Systems
Microbiology · 57d
Cleared Mar 02, 1984
MICROBIAL DIFFERENTIATION
K840031
Anaerobe Systems
Microbiology · 57d
Cleared Mar 02, 1984
NOVOBIOCIN DISC
K840483
Remel Co.
Microbiology · 25d
Cleared Mar 02, 1984
SPOTTEST ACRIDINE ORANGE STAIN
K840584
Difco Laboratories, Inc.
Microbiology · 23d
Cleared Feb 27, 1984
RIM GRAM REACTION SWAB
K840252
Austin Biological Laboratories
Microbiology · 35d
Cleared Feb 27, 1984
SPOTTEST OXIDASE REAGENT
K840575
Difco Laboratories, Inc.
Microbiology · 19d
Cleared Feb 27, 1984
SPOTTEST DMACA INDOLE REAGENT
K840576
Difco Laboratories, Inc.
Microbiology · 19d
Cleared Feb 27, 1984
SPOTTEST KOVACS' INDOLE REAGENT
K840577
Difco Laboratories, Inc.
Microbiology · 19d
Cleared Feb 27, 1984
SPOTTEST VOGES-PROSKAUER REAGENT A
K840578
Difco Laboratories, Inc.
Microbiology · 19d
Cleared Feb 27, 1984
SPOTTEST NITRATE REAGENT A
K840579
Difco Laboratories, Inc.
Microbiology · 19d
Cleared Feb 27, 1984
SPOTTEST NITRATE REAGENT B
K840580
Difco Laboratories, Inc.
Microbiology · 19d
Cleared Feb 27, 1984
SPOTTEST NITRATE REAGENT C
K840581
Difco Laboratories, Inc.
Microbiology · 19d
Cleared Feb 27, 1984
SPOTTEST FERRIC CHLORIDE REAGENT
K840582
Difco Laboratories, Inc.
Microbiology · 19d
Cleared Feb 27, 1984
SPOTTEST VOGES-PROSKAUER REAGENT B
K840583
Difco Laboratories, Inc.
Microbiology · 19d
Cleared Feb 13, 1984
DIFFERENTIATION DISKS HIPPURATE
K834581
Difco Laboratories, Inc.
Microbiology · 46d
Cleared Dec 30, 1983
HAEMOPHILUS IDENTIFICATION TEST KIT
K833963
Remel Co.
Microbiology · 44d
Cleared Dec 30, 1983
PVP IODINE
K834022
Remel Co.
Microbiology · 38d
Cleared Dec 30, 1983
BIO-ORNITHINE
K834028
Remel Co.
Microbiology · 38d
Cleared Dec 30, 1983
BIO-UREA
K834029
Remel Co.
Microbiology · 38d
Cleared Dec 08, 1983
BACTROL GRAM SLIDE
K833901
Difco Laboratories, Inc.
Pathology · 24d
Cleared Oct 04, 1983
RIME COLI KIT
K832587
Austin Biological Laboratories
Microbiology · 63d