Atlas FDA

JTZ

74 FDA 510(k) clearances · Product code

28 daysmedian time to decision
134 days90th percentile
74clearances measured

FDA profile

Official device name
Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth
Device class
Class II (moderate risk)
Regulation
21 CFR 866.1700
Medical specialty
Microbiology
Flags
Third-party review eligible
Adverse events (MAUDE)
1994: 1 · 1998: 4 · 2021: 20 · 2022: 27 · 2023: 20 · 2025: 20
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
MUELLER HINTON AGAR (K132491)Edge Biologicals, Inc.2014-06-30
MUELLER HINTON II BROTH (CATION-ADJUSTED) WITH LYSED HORSE BLOOD (K963036)Becton Dickinson Microbiology Systems1996-10-07
MUELLER HINTON AGAR WITH 5% SHEEP BLOOD (K960420)Becton Dickinson Microbiology Systems1996-04-04
MUELLER HINTON AGAR WITH 2% NACI (K960313)Remel, L.P.1996-03-25
CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST, MUELLER HINTON AGARS (K945911)Bioclinical Systems, Inc.1995-04-04
MUELLER HINTON AGAR W/OXACILLIN (K941985)Carr-Scarborough Microbiologicals, Inc.1994-08-24
MUELLER HINTON AGAR PLATES P3318/1&2/P3418/P34181 (K882351)Lakewood Biochemical Co., Inc.1988-06-28
MULLER HINTON BROTH (K880105)Hardy Media1988-03-30
MUELLER HINTON MEDIA (K873268)Central Media1987-11-04
MRSA SCREEN AGAR (MUELLER HINTON W/NACL & OXACIL.) (K870649)Hardy Media1987-04-14
CHOCOLATE MUELLER HINTON AGAR (K871097)bioMerieux, Inc.1987-04-03
MUELLER HINTON AGAR WITH 5% SHEEP BLOOD (K864247)Mds Laboratories, Inc.1987-03-31
MUELLER HINTON AGAR LARGE (K864246)Mds Laboratories, Inc.1987-03-31
MUELLER HINTON AGAR - SUPPLEMENTED (K864248)Mds Laboratories, Inc.1987-03-31
MUELLER HINTON AGAR SMALL (K864245)Mds Laboratories, Inc.1987-03-31
MUELLER HINTON AGAR W/4%NACL AND OXACILLIN (K863821)Gibco Laboratories Life Technologies, Inc.1986-10-09
BACTI PLATE (DERMATOLOGY) PRODUCT NO. PS-5000 (K861301)Troy Biologicals, Inc.1986-04-21
BIOGRAM (K854521)Giles Scientific, Inc.1985-12-23
MUELLER HINTON MEDIUM (K854451)R. Kent Richards, Inc.1985-11-18
APL MUELLER HINTON AGAR (K853238)Apl Medical Supplies1985-08-19
URINE DUO (K851225)Culture Kits, Inc.1985-08-13
MUELLER HINTON AGAR W/4% NACL W/ANTIBIOTICS (K850291)Remel Co.1985-05-10
MUELLER HINTON AGAR & MUELLER HINTON AGAR W/5% SHE (K851589)Preferred Micro-Media1985-04-30
MUELLER HINTON SENSITIVITY PLATE (K851518)Culture Kits, Inc.1985-04-29
MUELLER HINTON AGAR (K850715)Rapid City Regional Hospital, Inc.1985-03-22
MUELLER HINTON CHOCOLATE AGAR (K850843)Micro Media Laboratories1985-03-20
CULTURE MEDIUM FOR ANTIMICROBIAL SUSCEP. TESTING (K850731)Roseville Medical Laboratoriesu1985-03-20
MUELLER HINTON AGAR W/CHOCOLATE, MH W/CHOC (K850553)Hardy Media1985-03-11
SLT 220 WASHER FOR MICROITITERPLATES (K844892)Slt Labinstruments, Inc.1985-02-25
MUELLER HINTON BROTH (K842854)Anarobe Systems1984-08-17
CULTURE MEDIUM FOR ANTIMICROBIAL SUSCEP (K841834)Microline Scientific1984-05-14
MUELLER-HINTON AGAR (K841755)The Montana Deaconess Medical Center1984-05-14
MUELLER-HINTON BROTH (K841560)Gibco Laboratories Life Technologies, Inc.1984-05-07
CULTURE MEDIA FOR ANTIMICROBIAL SUSCEP (K840969)Chatham Biological1984-04-13
ANTIMICROBIAL SUSCEPT-CULTURE MEDIA (K841213)Smith River Biologicals1984-04-04
MUELLER HINTON AGAR W/BLOOD & COFACTOR (K841138)Anaerobe Systems1984-04-04
MUELLER HINTON AGAR W/WO BLOOD (K841137)Anaerobe Systems1984-03-26
CHOCOLATE AGAR MUELLERH-HINTON BASE (K840066)Otisville Biotech, Inc.1984-02-13
MUELLER-HINTON AGAR PLATE (K834421)Otisville Biotech, Inc.1984-02-03
MUELLER HINTON AGAR (K833861)American Biomedical Corp.1983-12-08
PREPARED MUELLER HINTON MED/100 MM (K833506)Lavco Laboratory, Inc.1983-12-01
CULTURE MEDIUM FOR ANTIMICROBIAL SUS (K832243)Carroll Biological Corp.1983-09-29
MUELLER HINTON (K830060)bioMerieux, Inc.1983-02-09
ACCESSORY MEDIA FOR FLOW TITERTEK MIC (K822119)Flow Laboratories, Inc.1982-08-03
MUELLER HINTON W/5% SHEEP'S BLOOD (K821607)Hardy Media1982-07-06
MUELLER HINTON MEDIUM (K821430)Interstate Media1982-06-01
MUELLER HINTON MED. W/5% SHEEP BLOOD (K821429)Interstate Media1982-06-01
MUELLER HINTON CHOCOLATE MED. ENRICHED (K821428)Interstate Media1982-06-01
ANTIMICROBIAL SUSCEP. TEST, MUELLER (K820846)Blue Ridge Media Co.1982-04-16
#19012 CHOCOLATE MUELLER HINTON-150X15MM (K820794)Biomedica, Inc.1982-04-08
#1904L MUELLER HINTON W/5% SHEEP BLOOD (K820793)Biomedica, Inc.1982-04-08
#19041-150X15MM MUELLER HINTON (K820792)Biomedica, Inc.1982-04-08
SENSI-TECT (K812581)Uti-Tect, Inc.1981-09-23
MUELLER HINTON AGAR (K811646)Hardy Media1981-07-02
MUELLER-HINTON (K811608)Micro Media Laboratories1981-06-25
MUELLER HINTON AGAR W/5% SHEEP BLOOD (K811473)Biomedia, Inc.1981-06-18
MUELLER HINTON AGAR (K811471)Biomedia, Inc.1981-06-18
MUELLER HINTON AGAR, POURED INTO A PLATE (K811472)Biomedia, Inc.1981-06-18
MUELLER HINTON BROTH (K811136)Acumedia Manufacturers, Inc.1981-05-05
MUELLER HINTON AGAR (K811049)Acumedia Manufacturers, Inc.1981-04-29
MUELLER HINTON BROTH (K802957)Gibco Laboratories Life Technologies, Inc.1980-12-22
MUELLER HINTON AGAR (K802498)Oxoid U.S.A., Inc.1980-11-12
MUELLER HINTON AGAR (K801901)Radiation Technology, Inc.1980-08-20
MUELLER HINTON AGAR (K800987)Quality Assurance Laboratory, Inc.1980-06-02
MUELLER HINTIN AGAR W/5% SHEEP BLOOD (K800979)Quality Assurance Laboratory, Inc.1980-05-23
CULTURE PLATES & TUBED MEDIA (K792481)Laboratory Products, Inc.1979-12-31
CULTURE AND SENSITIVITY KIT (K791413)Biomedia, Inc.1979-10-17
MUELLER HINTON CHOCOLATE (K791815)Isle Media and Sterile Products, Inc.1979-10-04
MUELLER HINTON MEDIUM W/SHEEP BLOOD (K791818)Isle Media and Sterile Products, Inc.1979-10-01
MUELLER-HINTON AGAR (K791624)American Laboratory Supply, Inc.1979-09-24
MUELLER HINTON AGARS (K791485)Isle Media and Sterile Products, Inc.1979-08-22
EMB/MUELLER-HINTON AGAR (K790369)Biomedia, Inc.1979-04-23
MUELLER HINTON AGAR WITH 5% SHEEP BLOOD (K780958)Pittsburgh Micro-Media, Inc.1978-10-24
MUELLER HINTON AGAR WITH THYMIDINE (K780959)Pittsburgh Micro-Media, Inc.1978-10-24

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