ClearanceBrief
Panels › Microbiology › Product code JSO · Class 2

Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar

Regulation 866.1700

0510(k)s in 12 months (40 all time)
0recalls in 12 months (56 all time)
18recalls that name a 510(k)
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Top companies in JSO

Decided510(k)Device and applicantCode
Apr 29, 2019K190553HardyCHROM CRE
Hardy Diagnostics
JSO
Jul 6, 2018K181092CHROMID CARBA agar (CARB)
Biomerieux S.A., FR
JSO
Dec 28, 2017K171061MRSASelect II
Bio-Rad, FR
JSO
May 1, 2017K162620Remel Spectra ESBL
Remel, Inc.
JSO
Nov 15, 2016K160512HardyCHROM ESBL
Hardy Diagnostics
JSO
Oct 25, 2016K162076chromID MRSA
bioMerieux, Inc.
JSO
Mar 11, 2016K151688chromID MRSA
bioMerieux, Inc.
JSO
Nov 6, 2012K122187VRESELECT CULTURE MEDIUM
Bio-Rad
JSO
Oct 21, 2011K103684VRESELECT CULTURE MEDIUM
Bio-Rad
JSO
May 4, 2011K102922HARDYCHROM MRSA
Hardy Diagnostics
JSO
Oct 29, 2010K100589MRSA SELECT - SKIN AND SOFT TISSUE WOUND SPECIMENS
Bio-Rad
JSO
Oct 8, 2010K092407REMEL SPECTRA MRSA
Remel, Inc.
JSO
Aug 20, 2010K092767BBL CHROMAGAR MRSA II
Becton, Dickinson & CO
JSO
Jul 15, 2010K092819REMEL SPECTRA VRE
Thermo Fisher Scientific
JSO
Mar 2, 2010K091025CHROMID VRE AGAR, MODEL: REF 43 851
bioMerieux, Inc.
JSO
Jul 17, 2009K091024CHROMID MRSA AGAR, MODEL: REF 43 841
bioMerieux, Inc.
JSO
Jun 13, 2008K081212MRSASELECT - EXTENDED INCUBATION
Bio-Rad
JSO
Feb 28, 2008K073027SPECTRA MRSA
Thermo Fisher Scientific
JSO
Sep 13, 2007K070361MRSASELECT
Bio-Rad
JSO
Nov 22, 2004K042812BBLCHROMAGAR MRSA
Becton, Dickinson & CO
JSO
Aug 28, 1997K972359REMEL BILE ESCULIN AZIDE AGAR W/6 MCG/ML VANCOMYCIN
Remel, L.P.
JSO
Jan 15, 1997K964560BHI W/VANCOMYCIN AGAR
Hardy Diagnostics
JSO
Oct 15, 1996K962744HAEMOPHILUS TEST MEDIUM AGAR (HTM)
Prepared Media Laboratory, Inc.
JSO
Apr 10, 1996K952595HAEMOPHILUS TEST MEDIUM (HTM)
Clinical Standards Laboratories, Inc.
JSO
Oct 16, 1995K951754CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST
Hardy Diagnostics
JSO
Feb 2, 1995K945569GCII AGAR WITH ISOVITALX(R) ENRICHMENT
Becton Dickinson Microbiology Systems
JSO
Oct 4, 1994K944554BRAIN HEART INFUSION AGAR
Carr-Scarborough Microbiologicals, Inc.
JSO
Sep 19, 1994K941444BHI AGAR WITH VANCOMYCIN
Remel Co.
JSO
Sep 19, 1994K941443SYNERGY QUAD
Remel Co.
JSO
Sep 24, 1993K932882GC II AGAR WITH ISOVITALEX
Becton Dickinson Microbiology Systems
JSO
Sep 21, 1993K932879G C II AGAR WITH SENSIVITALEX
Becton Dickinson Microbiology Systems
JSO
Jun 21, 1993K923892SMITH RIVER MICROBIOLOGICAL CULTURE MEDIA
Smith River Biologicals
JSO
Aug 22, 1990K903425HAEMOPHILUS TEST MEDIUM (HTM) BROTH
Bd Becton Dickinson Vacutainer Systems Preanalytic
JSO
Dec 13, 1989K894216HAEMOPHILUS TEST MEDIUM (HTM)AGAR
Bd Becton Dickinson Vacutainer Systems Preanalytic
JSO
Sep 6, 1989K894848HAEMOPHILUS TEST MEDIUM (BROTH)
Regional Media Laboratories
JSO
Jun 13, 1989K892928HAEMOPHILUS TEST MEDIUM (AGAR)
Remel Co.
JSO
Apr 18, 1988K881568WILKENS CHALGREN BROTH
Acumedia Manufacturers, Inc.
JSO
Apr 18, 1988K881567WILKENS CHALGREN AGAR
Acumedia Manufacturers, Inc.
JSO
Jun 18, 1981K811513WILKINS-CHALGREN ANAEROBE AGAR
Oxoid U.S.A., Inc.
JSO
Mar 10, 1977K770441GAR, COLUMBIA, W/5% HORSE BLOOD
Bd Becton Dickinson Vacutainer Systems Preanalytic
JSO

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