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, bioMerieux, Inc. and Bd Becton Dickinson Vacutainer Systems Preanalytic.

40
Total
40
Cleared
152d
Avg days
1977
Since

FDA 510(k) Cleared Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar Devices (Product Code JSO)

40 devices
1–24 of 40
Cleared Apr 29, 2019
HardyCHROM CRE
K190553
Hardy Diagnostics
Microbiology · 55d
Cleared Jul 06, 2018
CHROMID CARBA agar (CARB)
K181092
Biomerieux S.A.
Microbiology · 72d
Cleared Dec 28, 2017
MRSASelect II
K171061
Bio-Rad
Microbiology · 262d
Cleared Oct 25, 2016
chromID MRSA
K162076
bioMerieux, Inc.
Microbiology · 90d
Cleared Mar 11, 2016
chromID MRSA
K151688
bioMerieux, Inc.
Microbiology · 262d
Cleared Nov 06, 2012
VRESELECT CULTURE MEDIUM
K122187
Bio-Rad
Microbiology · 105d
Cleared Oct 21, 2011
VRESELECT CULTURE MEDIUM
K103684
Bio-Rad
Microbiology · 308d
Cleared Oct 29, 2010
MRSA SELECT - SKIN AND SOFT TISSUE WOUND SPECIMENS
K100589
Bio-Rad
Microbiology · 241d
Cleared Mar 02, 2010
CHROMID VRE AGAR, MODEL: REF 43 851
K091025
bioMerieux, Inc.
Microbiology · 326d
Cleared Jul 17, 2009
CHROMID MRSA AGAR, MODEL: REF 43 841
K091024
bioMerieux, Inc.
Microbiology · 98d
Cleared Jun 13, 2008
MRSASELECT - EXTENDED INCUBATION
K081212
Bio-Rad
Microbiology · 45d
Cleared Sep 13, 2007
MRSASELECT
K070361
Bio-Rad
Microbiology · 218d
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 Mar 10, 1977
GAR, COLUMBIA, W/5% HORSE BLOOD
K770441
Bd Becton Dickinson Vacutainer Systems Preanalytic
Microbiology · 3d

About Product Code JSO - Regulatory Context