JSX · Class I · 21 CFR 866.2660

FDA Product Code JSX: Kit, Identification, Neisseria Gonorrhoeae

Leading manufacturers include Remel Co., Medtex Laboratories, Inc. and Miles Laboratories, Inc..

16
Total
16
Cleared
73d
Avg days
1978
Since

FDA 510(k) Cleared Kit, Identification, Neisseria Gonorrhoeae Devices (Product Code JSX)

16 devices
1–16 of 16
Cleared Sep 18, 1996
GONOPOX TEST KIT
K960759
Medtex Laboratories, Inc.
Microbiology · 205d
Cleared Nov 02, 1992
NIZYME TEST KIT
K923566
Remel Co.
Microbiology · 108d
Cleared Aug 25, 1988
XACT NEISSERIA
K880511
Austin Biological Laboratories
Microbiology · 198d
Cleared Mar 20, 1987
NEISSERIA/BRANHAMELLA DIFFERENTIAL TEST
K870117
Pro-Lab, Inc.
Microbiology · 67d
Cleared Sep 05, 1985
QUAD FERM +
K853544
Analytical Products, Inc.
Microbiology · 10d
Cleared Dec 27, 1983
PHADEBACK G.C. POSITIVE CONTROLS
K833307
Pharmacia, Inc.
Microbiology · 95d
Cleared Mar 08, 1983
NEISSERIA IDENTIFICATION DISCS
K830364
Oxoid U.S.A., Inc.
Microbiology · 32d
Cleared Aug 18, 1981
IDS RAPIDS NH SYSTEMS
K812048
Carr-Scarborough Microbiologicals, Inc.
Microbiology · 29d
Cleared Jun 16, 1981
NEISSERIA-KWIK
K811412
Windsor Laboratories, Inc.
Chemistry · 28d
Cleared Apr 23, 1979
GONO-CELL
K782013
Abbott Laboratories
Microbiology · 139d
Cleared Aug 31, 1978
MICROCULT-GC CULTURE TEST
K781108
Miles Laboratories, Inc.
Microbiology · 62d

About Product Code JSX - Regulatory Context