Atlas FDA

JSO

40 FDA 510(k) clearances · Product code

114 daysmedian time to decision
321 days90th percentile
40clearances measured

FDA profile

Official device name
Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar
Device class
Class II (moderate risk)
Regulation
21 CFR 866.1700
Medical specialty
Microbiology
Flags
Third-party review eligible
Adverse events (MAUDE)
2016: 17 · 2017: 43 · 2018: 14 · 2021: 27 · 2025: 519 · 2026: 29
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
HardyCHROM CRE (K190553)Hardy Diagnostics2019-04-29
CHROMID CARBA agar (CARB) (K181092)Biomerieux S.A.2018-07-06
MRSASelect II (K171061)Bio-Rad2017-12-28
Remel Spectra ESBL (K162620)Remel, Inc.2017-05-01
HardyCHROM ESBL (K160512)Hardy Diagnostics2016-11-15
chromID MRSA (K162076)bioMerieux, Inc.2016-10-25
chromID MRSA (K151688)bioMerieux, Inc.2016-03-11
VRESELECT CULTURE MEDIUM (K122187)Bio-Rad2012-11-06
VRESELECT CULTURE MEDIUM (K103684)Bio-Rad2011-10-21
HARDYCHROM MRSA (K102922)Hardy Diagnostics2011-05-04
MRSA SELECT - SKIN AND SOFT TISSUE WOUND SPECIMENS (K100589)Bio-Rad2010-10-29
REMEL SPECTRA MRSA (K092407)Remel, Inc.2010-10-08
BBL CHROMAGAR MRSA II (K092767)Becton, Dickinson & CO2010-08-20
REMEL SPECTRA VRE (K092819)Thermo Fisher Scientific2010-07-15
CHROMID VRE AGAR, MODEL: REF 43 851 (K091025)bioMerieux, Inc.2010-03-02
CHROMID MRSA AGAR, MODEL: REF 43 841 (K091024)bioMerieux, Inc.2009-07-17
MRSASELECT - EXTENDED INCUBATION (K081212)Bio-Rad2008-06-13
SPECTRA MRSA (K073027)Thermo Fisher Scientific2008-02-28
MRSASELECT (K070361)Bio-Rad2007-09-13
BBLCHROMAGAR MRSA (K042812)Becton, Dickinson & CO2004-11-22
REMEL BILE ESCULIN AZIDE AGAR W/6 MCG/ML VANCOMYCIN (K972359)Remel, L.P.1997-08-28
BHI W/VANCOMYCIN AGAR (K964560)Hardy Diagnostics1997-01-15
HAEMOPHILUS TEST MEDIUM AGAR (HTM) (K962744)Prepared Media Laboratory, Inc.1996-10-15
HAEMOPHILUS TEST MEDIUM (HTM) (K952595)Clinical Standards Laboratories, Inc.1996-04-10
CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST (K951754)Hardy Diagnostics1995-10-16
GCII AGAR WITH ISOVITALX(R) ENRICHMENT (K945569)Becton Dickinson Microbiology Systems1995-02-02
BRAIN HEART INFUSION AGAR (K944554)Carr-Scarborough Microbiologicals, Inc.1994-10-04
BHI AGAR WITH VANCOMYCIN (K941444)Remel Co.1994-09-19
SYNERGY QUAD (K941443)Remel Co.1994-09-19
GC II AGAR WITH ISOVITALEX (K932882)Becton Dickinson Microbiology Systems1993-09-24
G C II AGAR WITH SENSIVITALEX (K932879)Becton Dickinson Microbiology Systems1993-09-21
SMITH RIVER MICROBIOLOGICAL CULTURE MEDIA (K923892)Smith River Biologicals1993-06-21
HAEMOPHILUS TEST MEDIUM (HTM) BROTH (K903425)Bd Becton Dickinson Vacutainer Systems Preanalytic1990-08-22
HAEMOPHILUS TEST MEDIUM (HTM)AGAR (K894216)Bd Becton Dickinson Vacutainer Systems Preanalytic1989-12-13
HAEMOPHILUS TEST MEDIUM (BROTH) (K894848)Regional Media Laboratories1989-09-06
HAEMOPHILUS TEST MEDIUM (AGAR) (K892928)Remel Co.1989-06-13
WILKENS CHALGREN BROTH (K881568)Acumedia Manufacturers, Inc.1988-04-18
WILKENS CHALGREN AGAR (K881567)Acumedia Manufacturers, Inc.1988-04-18
WILKINS-CHALGREN ANAEROBE AGAR (K811513)Oxoid U.S.A., Inc.1981-06-18
GAR, COLUMBIA, W/5% HORSE BLOOD (K770441)Bd Becton Dickinson Vacutainer Systems Preanalytic1977-03-10

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Every clearance here is in the API, with alerts when new ones post.