JTY · Class II · 21 CFR 866.2410

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

Leading manufacturers include Bd Becton Dickinson Vacutainer Systems Preanalytic, bioMerieux, Inc. and Biomed Diagnostics Incorporated.

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 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 09, 1983
THAYER-MARTIN, MODIFIED
K830061
bioMerieux, Inc.
Immunology · 29d
Cleared Feb 09, 1983
MARTIN-LEWIS AGAR
K830062
bioMerieux, Inc.
Immunology · 29d
Cleared Jul 23, 1981
GONOZYME (10 COPIES FRWD. W/ORIG. TO BG)
K812078
Abbott Laboratories
Microbiology
Cleared Oct 07, 1976
IMPROVED THAYER MARTIN MEDIUM
K760588
Bd Becton Dickinson Vacutainer Systems Preanalytic
Microbiology · 34d

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.