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

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

244 devices
1–24 of 244
Cleared Sep 01, 2005
IN-VITRO DIAGNOSTIC VAGINITIS TEST KIT
K050352
Ameritek Research, LLC
Chemistry · 202d
Cleared Apr 24, 1997
PYR SWAB
K970832
Remel, Inc.
Microbiology · 48d
Cleared Apr 17, 1997
GRAM SWAB
K970834
Remel, Inc.
Microbiology · 41d
Cleared Apr 02, 1997
INDOLE SWAB
K970833
Remel, Inc.
Microbiology · 26d
Cleared Feb 06, 1997
LYFO(TM) DIFFERENTIAL DISK-BACITRACIN
K970009
Microbiologics, Inc.
Microbiology · 35d
Cleared Oct 08, 1996
IDS RAPID CB PLUS SYSTEM
K962966
Innovative Diagnostic Systems, Inc.
Microbiology · 70d
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 29, 1996
GIBSON ID-M. CAT.
K955826
Gibson Laboratories, Inc.
Microbiology · 65d
Cleared Feb 06, 1996
DRYSLIDE CARTARRHALIS
K954783
Difco Laboratories, Inc.
Microbiology · 112d
Cleared Dec 20, 1995
LYFO(TM) DIFFERIENTAL DISK-PYR
K954812
Microbiologics, Inc.
Microbiology · 62d
Cleared Nov 20, 1995
GIBSON ID A.E. TEST
K953247
Gibson Laboratories, Inc.
Microbiology · 132d
Cleared Aug 24, 1995
LYFO(TM) DIFFERENTIAL DISK
K951889
Microbiologics, Inc.
Microbiology · 122d
Cleared May 05, 1995
B-L RED(TM) DISCS
K950346
Oxis Intl., Inc.
Microbiology · 98d
Cleared Apr 24, 1995
LYFO(TM) DIFFERENTIAL DISK-SPS
K945880
Microbiologics, Inc.
Microbiology · 144d
Cleared Apr 24, 1995
LYFO(TM) DIFFERENTIAL DISK-STERILE DISK
K945881
Microbiologics, Inc.
Microbiology · 144d
Cleared Apr 24, 1995
LYFO(TM) DIFFERENTIAL DISK-BILE
K945882
Microbiologics, Inc.
Microbiology · 144d
Cleared Apr 24, 1995
LYFO(TM) DIFFERENTIAL DISK-BILE ESCULIN
K945883
Microbiologics, Inc.
Microbiology · 144d
Cleared Sep 14, 1994
SWABZYME OXIDASE
K934130
E-Y Laboratories, Inc.
Microbiology · 394d
Cleared Sep 09, 1994
GONOCHEK-II, MODIFICATION
K934125
E-Y Laboratories, Inc.
Microbiology · 393d
Cleared Sep 09, 1994
B-LACTAMASE REAGENT TUBES
K940161
E-Y Laboratories, Inc.
Microbiology · 240d
Cleared Sep 09, 1994
GONOCHEK II REAGENT TUBES
K940162
E-Y Laboratories, Inc.
Microbiology · 240d
Cleared Aug 26, 1994
STREP-A-CHEK
K934129
E-Y Laboratories, Inc.
Microbiology · 379d
Cleared Aug 26, 1994
STREP-A-CHEK(TM) REAGENT STRIPS
K940020
E-Y Laboratories, Inc.
Microbiology · 235d

About Product Code JTO - Regulatory Context