JSO · Class II · 21 CFR 866.1700

FDA Product Code JSO: Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar

Leading manufacturers include Bio-Rad, Hardy Diagnostics and bioMerieux, Inc..

40
Total
40
Cleared
152d
Avg days
1977
Since
40 devices
25–40 of 40
Cleared Oct 16, 1995
CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST
K951754
Hardy Diagnostics
Microbiology · 182d
Cleared Feb 02, 1995
GCII AGAR WITH ISOVITALX(R) ENRICHMENT
K945569
Becton Dickinson Microbiology Systems
Microbiology · 114d
Cleared Oct 04, 1994
BRAIN HEART INFUSION AGAR
K944554
Carr-Scarborough Microbiologicals, Inc.
Microbiology · 18d
Cleared Sep 19, 1994
SYNERGY QUAD
K941443
Remel Co.
Microbiology · 179d
Cleared Sep 19, 1994
BHI AGAR WITH VANCOMYCIN
K941444
Remel Co.
Microbiology · 179d
Cleared Sep 24, 1993
GC II AGAR WITH ISOVITALEX
K932882
Becton Dickinson Microbiology Systems
Microbiology · 102d
Cleared Sep 21, 1993
G C II AGAR WITH SENSIVITALEX
K932879
Becton Dickinson Microbiology Systems
Microbiology · 99d
Cleared Aug 22, 1990
HAEMOPHILUS TEST MEDIUM (HTM) BROTH
K903425
Bd Becton Dickinson Vacutainer Systems Preanalytic
Microbiology · 22d
Cleared Dec 13, 1989
HAEMOPHILUS TEST MEDIUM (HTM)AGAR
K894216
Bd Becton Dickinson Vacutainer Systems Preanalytic
Microbiology · 177d
Cleared Jun 13, 1989
HAEMOPHILUS TEST MEDIUM (AGAR)
K892928
Remel Co.
Microbiology · 53d
Cleared Apr 18, 1988
WILKENS CHALGREN AGAR
K881567
Acumedia Manufacturers, Inc.
Microbiology · 7d
Cleared Apr 18, 1988
WILKENS CHALGREN BROTH
K881568
Acumedia Manufacturers, Inc.
Microbiology · 7d
Cleared Jun 18, 1981
WILKINS-CHALGREN ANAEROBE AGAR
K811513
Oxoid U.S.A., Inc.
Toxicology · 21d
Cleared Mar 10, 1977
GAR, COLUMBIA, W/5% HORSE BLOOD
K770441
Bd Becton Dickinson Vacutainer Systems Preanalytic
Microbiology · 3d