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 Austin Biological Laboratories.

244
Total
244
Cleared
59d
Avg days
1976
Since

FDA 510(k) Cleared Discs, Strips And Reagents, Microorganism Differentiation Devices (Product Code JTO)

244 devices
1–24 of 244
Cleared Jun 17, 1996
COLISCREEN
K961191
Hardy Diagnostics
Microbiology · 83d
Cleared Apr 18, 1996
M. CAT BUTYRATE DISK
K960996
Hardy Diagnostics
Microbiology · 37d
Cleared Feb 06, 1996
DRYSLIDE CARTARRHALIS
K954783
Difco Laboratories, Inc.
Microbiology · 112d
Cleared Jun 30, 1994
DISPENS-O-DISC(TM) NITROCEFIN
K941016
Difco Laboratories, Inc.
Microbiology · 119d
Cleared May 20, 1994
BACTICARD STREP
K936021
Remel Co.
Microbiology · 154d
Cleared Feb 23, 1994
BACTICARD E. COLI
K934986
Remel Co.
Microbiology · 127d
Cleared Dec 15, 1993
PYR TEST KIT
K931865
Hardy Diagnostics
Microbiology · 245d
Cleared Oct 28, 1993
BACTICARD STREP
K933514
Remel Co.
Microbiology · 100d
Cleared Jun 15, 1993
NINHYDRIN REAGENT
K931862
Hardy Diagnostics
Microbiology · 62d
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 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

About Product Code JTO - Regulatory Context