JTY · Class II · 21 CFR 866.2410

FDA Product Code JTY: Culture Media, For Isolation Of Pathogenic Neisseria

Leading manufacturers include Granite Diagnostics, Inc., Isle Media and Sterile Products, Inc. and Otisville Biotech, Inc..

83
Total
83
Cleared
44d
Avg days
1976
Since
Stable submission activity - 0 submissions in the last 2 years

FDA 510(k) Cleared Culture Media, For Isolation Of Pathogenic Neisseria Devices (Product Code JTY)

83 devices
1–24 of 83
Cleared Oct 20, 2021
InTray GC
K210511
Biomed Diagnostics Incorporated
Microbiology · 239d
Cleared Dec 16, 1999
INTRAY GC
K993033
Biomed Diagnostics, Inc.
Microbiology · 98d
Cleared Feb 16, 1996
GC BASE W/ 1% GCHI
K954986
Remel, L.P.
Microbiology · 108d
Cleared Dec 21, 1993
THAYER MARTIN, MODIFIED PILL POCKET
K934331
Hardy Diagnostics
Microbiology · 109d
Cleared Dec 17, 1993
TRANSGROW
K934330
Hardy Diagnostics
Microbiology · 105d
Cleared Dec 15, 1993
MARTIN LEWIS WITH LINOCMYCIN
K931864
Hardy Diagnostics
Microbiology · 245d
Cleared Apr 18, 1988
CASMAN MEDIUM BASE
K881527
Acumedia Manufacturers, Inc.
Microbiology · 10d
Cleared Apr 18, 1988
PROTEOSE NO. 3 AGAR
K881552
Acumedia Manufacturers, Inc.
Microbiology · 10d
Cleared Apr 29, 1987
MARTIN-LEWIS AGAR W/REDUCED VANCOMYCIN C0226
K871541
Gibco Laboratories Life Technologies, Inc.
Microbiology · 9d
Cleared Mar 31, 1987
THAYER-MARTIN JEMBEC
K864252
Mds Laboratories, Inc.
Microbiology · 154d
Cleared Mar 31, 1987
THAYER MARTIN AGAR
K864253
Mds Laboratories, Inc.
Microbiology · 154d
Cleared Feb 03, 1987
GC-LECT(TM)
K864803
Bd Becton Dickinson Vacutainer Systems Preanalytic
Microbiology · 56d
Cleared Oct 31, 1986
MODIFIED N.Y.C. FERMENTATION MEDIUM BASE
K864078
Bd Becton Dickinson Vacutainer Systems Preanalytic
Microbiology · 11d
Cleared Feb 24, 1986
BIOTIS MODIFIED THAYER MARTIN
K860384
Otisville Biotech, Inc.
Microbiology · 21d
Cleared Aug 19, 1985
APL MARTIN LEWIS MEDIUM
K853237
Apl Medical Supplies
Microbiology · 18d
Cleared May 08, 1985
CHOCOLATE MUELLER HINTON AGAR
K851579
Preferred Micro-Media
Microbiology · 22d
Cleared Apr 30, 1985
THAYER MARTIN AGAR & MODIFIED THAYER AGAR
K851587
Preferred Micro-Media
Microbiology · 14d
Cleared Mar 20, 1985
MOD THAYER MARTIN MARTIN LEWIS
K850841
Micro Media Laboratories
Microbiology · 19d
Cleared Oct 10, 1984
BIOTIS MARTIN LEWIS AGAR
K843817
Otisville Biotech, Inc.
Microbiology · 12d
Cleared Feb 13, 1984
CHOCOLATE AGAR GC BASE PLATE
K840065
Otisville Biotech, Inc.
Microbiology · 35d
Cleared Feb 13, 1984
THAYER-MARTIN AGAR PLATE
K840067
Otisville Biotech, Inc.
Microbiology · 35d
Cleared Sep 29, 1983
NYC-GC MEDIA
K832948
Otisville Biotech, Inc.
Microbiology · 30d
Cleared May 18, 1983
MODIFIED NEW YORK MEDIUM
K831359
Gibco Laboratories Life Technologies, Inc.
Microbiology · 22d
Cleared May 13, 1983
TILL-U-TEST G.C. GONOCOCUS SLIDE
K831268
Pasco Laboratories, Inc.
Microbiology · 25d

About Product Code JTY - Regulatory Context

510(k) Submission Activity

83 total 510(k) submissions under product code JTY since 1976, with 83 receiving FDA clearance (average review time: 44 days).

Submission volume has remained relatively stable over the observed period, with 0 submissions in the last 24 months.