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 Isle Media and Sterile 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 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 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 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 Sep 12, 1983
INDOLE NITRATE MEDIUM
K832568
Acumedia Manufacturers, Inc.
Microbiology · 41d
Cleared Jul 08, 1982
TRIPLE SUGAR IRON AGAR SLANT
K821592
Hardy Media
Microbiology · 41d
Cleared Nov 06, 1981
BCYE MEDIUM
K812911
Gibco Laboratories Life Technologies, Inc.
Microbiology · 18d
Cleared May 08, 1980
RAPID FERMENTATION AGAR (RFA)
K800734
Remel Co.
Microbiology · 36d
Cleared Dec 31, 1979
SIM MEDIUM
K792420
Isle Media and Sterile Products, Inc.
Microbiology · 34d
Cleared Dec 27, 1979
DECARBOXYLASE MOELLER BASE WITH OR WITH-
K792425
Isle Media and Sterile Products, Inc.
Microbiology · 30d
Cleared Aug 22, 1979
TRIPLE SUGAR IRON AGAR (TSI AGAR)
K791473
Isle Media and Sterile Products, Inc.
Microbiology · 26d

About Product Code JSE - Regulatory Context