JSE · Class I · 21 CFR 866.2320

FDA Product Code JSE: Culture Media, Multiple Biochemical Test

Leading manufacturers include Hardy Media, Otisville Biotech, Inc. and Analytical Products, Inc..

53
Total
53
Cleared
29d
Avg days
1977
Since

FDA 510(k) Cleared Culture Media, Multiple Biochemical Test Devices (Product Code JSE)

53 devices
1–24 of 53
Cleared Jul 25, 1996
MLX MICROTITER PLATE LUMINOMETER
K962265
Dynatech Laboratories, Inc.
Chemistry · 43d
Cleared Oct 12, 1988
X-ACT UREA/TDA
K883995
Pro-Lab, Inc.
Microbiology · 22d
Cleared Oct 12, 1988
X-ACT LDC/IND
K883996
Pro-Lab, Inc.
Microbiology · 22d
Cleared Mar 31, 1988
MRVP BROTH
K880116
Hardy Media
Microbiology · 85d
Cleared Mar 31, 1988
MIL MEDIUM
K880133
Hardy Media
Microbiology · 85d
Cleared Nov 20, 1987
KLIGLER IRON AGAR AND TRIPLE SUGAR IRON AGAR
K874537
Lakewood Biochemical Co., Inc.
Microbiology · 17d
Cleared Apr 03, 1987
CYSTINE TRYPTIC AGAR W/O CARBOHYDRATES
K871096
bioMerieux, Inc.
Microbiology · 16d
Cleared Jan 05, 1987
MICRODILUTION IDENTIFICATION PANELS
K864674
American Micro Scan
Microbiology · 34d
Cleared Jul 03, 1986
BIOTIS LITMUS MILK
K862393
Otisville Biotech, Inc.
Microbiology · 9d
Cleared Feb 24, 1986
BIOTIS SIM MEDIUM
K860412
Otisville Biotech, Inc.
Microbiology · 21d
Cleared Feb 24, 1986
BIOTIS TSI
K860413
Otisville Biotech, Inc.
Microbiology · 21d
Cleared Feb 24, 1986
BIOTIS ORNITHINE INDOLE MOTILITY MEDIA
K860414
Otisville Biotech, Inc.
Microbiology · 21d
Cleared Feb 24, 1986
BIOTIS SIMMON CITRATE AGAR
K860415
Otisville Biotech, Inc.
Microbiology · 21d
Cleared Feb 20, 1986
AUSTIN ENTERIC SYSTEM
K860194
Austin Biological Laboratories
Microbiology · 29d
Cleared Mar 29, 1985
CTAPI - NEISSERA SCREEN
K850982
Analytical Products, Inc.
Microbiology · 18d
Cleared Mar 11, 1985
KLIGLER IRON AGAR KIA
K850546
Hardy Media
Microbiology · 28d
Cleared Mar 11, 1985
MOTILITY INDOLE ORNITHINE AGAR
K850547
Hardy Media
Microbiology · 28d
Cleared Mar 11, 1985
LYSINE IRON AGAR LIA
K850548
Hardy Media
Microbiology · 28d
Cleared Mar 11, 1985
SIM MEDIUM
K850551
Hardy Media
Microbiology · 28d
Cleared Oct 10, 1984
BIOTIS KLIGLER IRON AGAR
K843768
Otisville Biotech, Inc.
Microbiology · 15d
Cleared Jul 02, 1984
BIOTIS LD-PRESUMPTO QUADRANT PLATE
K842424
Otisville Biotech, Inc.
Microbiology · 12d
Cleared Jul 02, 1984
RIM STREP KIT
K842451
Austin Biological Laboratories
Microbiology · 10d
Cleared Dec 22, 1983
KLIGLER IRON AGAR
K834001
Micro Media Laboratories
Microbiology · 31d
Cleared Dec 22, 1983
LYSINE IRON AGAR
K834002
Micro Media Laboratories
Microbiology · 31d

About Product Code JSE - Regulatory Context