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
25–48 of 244
Cleared May 12, 1993
OXYSTRIP
K930693
Hardy Diagnostics
Microbiology · 91d
Cleared May 12, 1993
CATALASE REAGENT
K931414
Hardy Diagnostics
Microbiology · 90d
Cleared May 11, 1993
BACTIDROP(TM) MUCAP
K930878
Remel Co.
Microbiology · 81d
Cleared May 11, 1993
FERRIC CHLORID REAGENT, 10%
K931413
Hardy Diagnostics
Microbiology · 89d
Cleared Apr 23, 1993
NITRATE REAGENTS A, B AND C
K930717
Hardy Diagnostics
Microbiology · 71d
Cleared Apr 23, 1993
INDOLE SPOT & INDOLE KOVACS REAGENT
K930718
Hardy Diagnostics
Microbiology · 71d
Cleared Apr 23, 1993
VOGUES-PROSKAUER REAGENT A & B
K930720
Hardy Diagnostics
Microbiology · 71d
Cleared Jan 26, 1993
BBL PYR REAGENT DROPPERS
K926254
Becton Dickinson Microbiology Systems
Microbiology · 39d
Cleared Jan 26, 1993
BBL NITRATE A, B REAGENT DROPPERS
K926255
Becton Dickinson Microbiology Systems
Microbiology · 39d
Cleared Jan 26, 1993
BBL NINHYDRIN REAGENT DROPPERS
K926256
Becton Dickinson Microbiology Systems
Microbiology · 39d
Cleared Jan 15, 1993
DRYSLIDE(TM) INDOLE
K925747
Difco Laboratories, Inc.
Microbiology · 63d
Cleared Oct 05, 1992
INDOXYL ACETATE DISK
K923700
Remel Co.
Microbiology · 73d
Cleared Sep 28, 1992
LAP DISK
K923827
Remel Co.
Microbiology · 60d
Cleared Jun 19, 1992
BACTIDROP INDOLE (ERLICH'S)
K920973
Remel Co.
Microbiology · 109d
Cleared Jun 19, 1992
DRYSLIDE(TM), PYR
K921583
Difco Laboratories, Inc.
Microbiology · 102d
Cleared May 22, 1992
BACTIDROP NINHYDRIN
K920971
Remel Co.
Microbiology · 81d
Cleared May 22, 1992
BACTIDROP PYR
K920972
Remel Co.
Microbiology · 81d
Cleared Apr 22, 1992
NIACIN CONTROL DISKS
K920257
Remel Co.
Microbiology · 92d
Cleared Sep 23, 1991
BACTIDROP(TM) FERRIC CHLORIDE (10%)
K913002
Remel Co.
Microbiology · 77d
Cleared Sep 23, 1991
BACTIDROP(TM) VOGES-PROSKAUER A
K913003
Remel Co.
Microbiology · 77d
Cleared Sep 23, 1991
BACTIDROP(TM) DOBELL & O'CONNOR IODINE
K913006
Remel Co.
Microbiology · 77d
Cleared Sep 23, 1991
BACTIDROP(TM) VOGES-PROSKAUER B
K913007
Remel Co.
Microbiology · 77d
Cleared Sep 23, 1991
BACTIDROP(TM) OXIDASE
K913008
Remel Co.
Microbiology · 77d
Cleared Sep 19, 1991
BACTIDROP (TM) NITRATE B
K913010
Remel Co.
Microbiology · 73d