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Innolitics
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Review Panel
Cardiovascular
Review Panel
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Hematology
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Miscellaneous
Miscellaneous
Subpart B—Biological Stains
CFR Sub-Part
Subpart B—Clinical Chemistry Test Systems
CFR Sub-Part
Subpart B—Diagnostic Devices
CFR Sub-Part
JSO
Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar
2
Product Code
JTN
Susceptibility Test Discs, Antimicrobial
2
Product Code
JTT
Susceptibility Test Powders, Antimicrobial
2
Product Code
JTZ
Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth
2
Product Code
K
13
2491
MUELLER HINTON AGAR
2
Cleared 510(K)
K
96
3036
MUELLER HINTON II BROTH (CATION-ADJUSTED) WITH LYSED HORSE BLOOD
2
Cleared 510(K)
K
96
0420
MUELLER HINTON AGAR WITH 5% SHEEP BLOOD
2
Cleared 510(K)
K
96
0313
MUELLER HINTON AGAR WITH 2% NACI
2
Cleared 510(K)
K
94
5911
CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST, MUELLER HINTON AGARS
2
Cleared 510(K)
K
94
1985
MUELLER HINTON AGAR W/OXACILLIN
2
Cleared 510(K)
K
88
2351
MUELLER HINTON AGAR PLATES P3318/1&2/P3418/P34181
2
Cleared 510(K)
K
88
0105
MULLER HINTON BROTH
2
Cleared 510(K)
K
87
3268
MUELLER HINTON MEDIA
2
Cleared 510(K)
K
87
0649
MRSA SCREEN AGAR (MUELLER HINTON W/NACL & OXACIL.)
2
Cleared 510(K)
K
87
1097
CHOCOLATE MUELLER HINTON AGAR
2
Cleared 510(K)
K
86
4247
MUELLER HINTON AGAR WITH 5% SHEEP BLOOD
2
Cleared 510(K)
K
86
4248
MUELLER HINTON AGAR - SUPPLEMENTED
2
Cleared 510(K)
K
86
4246
MUELLER HINTON AGAR LARGE
2
Cleared 510(K)
K
86
4245
MUELLER HINTON AGAR SMALL
2
Cleared 510(K)
K
86
3821
MUELLER HINTON AGAR W/4%NACL AND OXACILLIN
2
Cleared 510(K)
K
86
1301
BACTI PLATE (DERMATOLOGY) PRODUCT NO. PS-5000
2
Cleared 510(K)
K
85
4521
BIOGRAM
2
Cleared 510(K)
K
85
4451
MUELLER HINTON MEDIUM
2
Cleared 510(K)
K
85
3238
APL MUELLER HINTON AGAR
2
Cleared 510(K)
K
85
1225
URINE DUO
2
Cleared 510(K)
K
85
0291
MUELLER HINTON AGAR W/4% NACL W/ANTIBIOTICS
2
Cleared 510(K)
K
85
1589
MUELLER HINTON AGAR & MUELLER HINTON AGAR W/5% SHE
2
Cleared 510(K)
K
85
1518
MUELLER HINTON SENSITIVITY PLATE
2
Cleared 510(K)
K
85
0715
MUELLER HINTON AGAR
2
Cleared 510(K)
K
85
0843
MUELLER HINTON CHOCOLATE AGAR
2
Cleared 510(K)
K
85
0731
CULTURE MEDIUM FOR ANTIMICROBIAL SUSCEP. TESTING
2
Cleared 510(K)
K
85
0553
MUELLER HINTON AGAR W/CHOCOLATE, MH W/CHOC
2
Cleared 510(K)
K
84
4892
SLT 220 WASHER FOR MICROITITERPLATES
2
Cleared 510(K)
K
84
2854
MUELLER HINTON BROTH
2
Cleared 510(K)
K
84
1755
MUELLER-HINTON AGAR
2
Cleared 510(K)
K
84
1834
CULTURE MEDIUM FOR ANTIMICROBIAL SUSCEP
2
Cleared 510(K)
K
84
1560
MUELLER-HINTON BROTH
2
Cleared 510(K)
K
84
0969
CULTURE MEDIA FOR ANTIMICROBIAL SUSCEP
2
Cleared 510(K)
K
84
1138
MUELLER HINTON AGAR W/BLOOD & COFACTOR
2
Cleared 510(K)
K
84
1213
ANTIMICROBIAL SUSCEPT-CULTURE MEDIA
2
Cleared 510(K)
K
84
1137
MUELLER HINTON AGAR W/WO BLOOD
2
Cleared 510(K)
K
84
0066
CHOCOLATE AGAR MUELLERH-HINTON BASE
2
Cleared 510(K)
K
83
4421
MUELLER-HINTON AGAR PLATE
2
Cleared 510(K)
K
83
3861
MUELLER HINTON AGAR
2
Cleared 510(K)
K
83
3506
PREPARED MUELLER HINTON MED/100 MM
2
Cleared 510(K)
K
83
2243
CULTURE MEDIUM FOR ANTIMICROBIAL SUS
2
Cleared 510(K)
K
83
0060
MUELLER HINTON
2
Cleared 510(K)
K
82
2119
ACCESSORY MEDIA FOR FLOW TITERTEK MIC
2
Cleared 510(K)
K
82
1607
MUELLER HINTON W/5% SHEEP'S BLOOD
2
Cleared 510(K)
K
82
1428
MUELLER HINTON CHOCOLATE MED. ENRICHED
2
Cleared 510(K)
K
82
1430
MUELLER HINTON MEDIUM
2
Cleared 510(K)
K
82
1429
MUELLER HINTON MED. W/5% SHEEP BLOOD
2
Cleared 510(K)
K
82
0846
ANTIMICROBIAL SUSCEP. TEST, MUELLER
2
Cleared 510(K)
K
82
0794
#19012 CHOCOLATE MUELLER HINTON-150X15MM
2
Cleared 510(K)
K
82
0792
#19041-150X15MM MUELLER HINTON
2
Cleared 510(K)
K
82
0793
#1904L MUELLER HINTON W/5% SHEEP BLOOD
2
Cleared 510(K)
K
81
2581
SENSI-TECT
2
Cleared 510(K)
K
81
1646
MUELLER HINTON AGAR
2
Cleared 510(K)
K
81
1608
MUELLER-HINTON
2
Cleared 510(K)
K
81
1471
MUELLER HINTON AGAR
2
Cleared 510(K)
K
81
1473
MUELLER HINTON AGAR W/5% SHEEP BLOOD
2
Cleared 510(K)
K
81
1472
MUELLER HINTON AGAR, POURED INTO A PLATE
2
Cleared 510(K)
K
81
1136
MUELLER HINTON BROTH
2
Cleared 510(K)
K
81
1049
MUELLER HINTON AGAR
2
Cleared 510(K)
K
80
2957
MUELLER HINTON BROTH
2
Cleared 510(K)
K
80
2498
MUELLER HINTON AGAR
2
Cleared 510(K)
K
80
1901
MUELLER HINTON AGAR
2
Cleared 510(K)
K
80
0987
MUELLER HINTON AGAR
2
Cleared 510(K)
K
80
0979
MUELLER HINTIN AGAR W/5% SHEEP BLOOD
2
Cleared 510(K)
K
79
2481
CULTURE PLATES & TUBED MEDIA
2
Cleared 510(K)
K
79
1413
CULTURE AND SENSITIVITY KIT
2
Cleared 510(K)
K
79
1815
MUELLER HINTON CHOCOLATE
2
Cleared 510(K)
K
79
1818
MUELLER HINTON MEDIUM W/SHEEP BLOOD
2
Cleared 510(K)
K
79
1624
MUELLER-HINTON AGAR
2
Cleared 510(K)
K
79
1485
MUELLER HINTON AGARS
2
Cleared 510(K)
K
79
0369
EMB/MUELLER-HINTON AGAR
2
Cleared 510(K)
K
78
0958
MUELLER HINTON AGAR WITH 5% SHEEP BLOOD
2
Cleared 510(K)
K
78
0959
MUELLER HINTON AGAR WITH THYMIDINE
2
Cleared 510(K)
JWY
Manual Antimicrobial Susceptibility Test Systems
2
Product Code
LIE
Reagent/Device, Inoculum Calibration
2
Product Code
LKA
Culture Media, Antimicrobial Susceptibility Test
2
Product Code
LON
System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
2
Product Code
LOP
Solution, Antimicrobial
2
Product Code
LRG
Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems
2
Product Code
LTT
Panels, Test, Susceptibility, Antimicrobial
2
Product Code
LTW
Susceptibility Test Cards, Antimicrobial
2
Product Code
LTX
Discs, Elution
2
Product Code
MJA
Susceptibility Test Powders, Antimycobacterial
2
Product Code
MJD
Culture Media, Antimycobacteria, Susceptibility Test
2
Product Code
MJE
Culture Media, Antifungal, Susceptibility Test
2
Product Code
MYI
System, Test, Genotypic Detection, Resistant Markers, Staphylococcus Colonies
2
Product Code
NGZ
Susceptibility Test Plate, Antifungal
2
Product Code
NIJ
System, Test, Genotypic Detection, Resistant Markers, Enterococcus Species
2
Product Code
NQX
System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen
2
Product Code
PMY
System, Nucleic Acid Amplification Test, Dna, Carbapenem Non-Susceptible Gram Negative Organism, Colony
2
Product Code
POC
System, Nucleic Acid Amplification Test, Dna, Antimicrobial Resistance Marker, Direct Specimen
2
Product Code
PRH
Positive Blood Culture Identification And Ast Kit
2
Product Code
PTJ
Phenotypic Test Kit, Non-Susceptible/Elevated Mic Organisms, Cultured Isolates
2
Product Code
QIV
Culture-Based Short-Term Incubation Antimicrobial Resistance Assay
2
Product Code
QZX
Positive Blood Culture Processor For Inoculum Preparation Used For Antimicrobial Susceptibility Testing
2
Product Code
SAN
Automated Antimicrobial Susceptibility Test System For Positive Blood Culture Samples
2
Product Code
Subpart C—Clinical Laboratory Instruments
CFR Sub-Part
Subpart C—Microbiology Devices
CFR Sub-Part
Subpart D—Serological Reagents
CFR Sub-Part
Subpart F—Immunological Test Systems
CFR Sub-Part
Neurology
Review Panel
Obstetrical and Gynecological
Review Panel
Ophthalmic
Review Panel
Orthopedic
Review Panel
Pathology
Review Panel
Physical Medicine
Review Panel
Radiology
Review Panel
General and Plastic Surgery
Review Panel
Toxicology
Review Panel
Medical Genetics
Review Panel
Unknown
Review Panel
Last synced on 25 January 2026 at 3:41 am
MI
/
subpart-b—diagnostic-devices
/
JTZ
/
K791815
View Source
MUELLER HINTON CHOCOLATE
Page Type
Cleared 510(K)
PDF
PDF
* The FDA doesn't provide PDFs for all submissions.
PDF
Analyzed PDF
510(k) Number
K791815
510(k) Type
Traditional
Applicant
ISLE MEDIA AND STERILE PRODUCTS, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
10/4/1979
Days to Decision
20 days
FDA Browser
by
Innolitics
Anesthesiology
Cardiovascular
Chemistry
Dental
Ear, Nose, Throat
Gastroenterology and Urology
General Hospital
Hematology
Immunology
Microbiology
Miscellaneous
Subpart B—Biological Stains
Subpart B—Clinical Chemistry Test Systems
Subpart B—Diagnostic Devices
JSO
Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar
JTN
Susceptibility Test Discs, Antimicrobial
JTT
Susceptibility Test Powders, Antimicrobial
JTZ
Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth
K
13
2491
MUELLER HINTON AGAR
K
96
3036
MUELLER HINTON II BROTH (CATION-ADJUSTED) WITH LYSED HORSE BLOOD
K
96
0420
MUELLER HINTON AGAR WITH 5% SHEEP BLOOD
K
96
0313
MUELLER HINTON AGAR WITH 2% NACI
K
94
5911
CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST, MUELLER HINTON AGARS
K
94
1985
MUELLER HINTON AGAR W/OXACILLIN
K
88
2351
MUELLER HINTON AGAR PLATES P3318/1&2/P3418/P34181
K
88
0105
MULLER HINTON BROTH
K
87
3268
MUELLER HINTON MEDIA
K
87
0649
MRSA SCREEN AGAR (MUELLER HINTON W/NACL & OXACIL.)
K
87
1097
CHOCOLATE MUELLER HINTON AGAR
K
86
4247
MUELLER HINTON AGAR WITH 5% SHEEP BLOOD
K
86
4248
MUELLER HINTON AGAR - SUPPLEMENTED
K
86
4246
MUELLER HINTON AGAR LARGE
K
86
4245
MUELLER HINTON AGAR SMALL
K
86
3821
MUELLER HINTON AGAR W/4%NACL AND OXACILLIN
K
86
1301
BACTI PLATE (DERMATOLOGY) PRODUCT NO. PS-5000
K
85
4521
BIOGRAM
K
85
4451
MUELLER HINTON MEDIUM
K
85
3238
APL MUELLER HINTON AGAR
K
85
1225
URINE DUO
K
85
0291
MUELLER HINTON AGAR W/4% NACL W/ANTIBIOTICS
K
85
1589
MUELLER HINTON AGAR & MUELLER HINTON AGAR W/5% SHE
K
85
1518
MUELLER HINTON SENSITIVITY PLATE
K
85
0715
MUELLER HINTON AGAR
K
85
0843
MUELLER HINTON CHOCOLATE AGAR
K
85
0731
CULTURE MEDIUM FOR ANTIMICROBIAL SUSCEP. TESTING
K
85
0553
MUELLER HINTON AGAR W/CHOCOLATE, MH W/CHOC
K
84
4892
SLT 220 WASHER FOR MICROITITERPLATES
K
84
2854
MUELLER HINTON BROTH
K
84
1755
MUELLER-HINTON AGAR
K
84
1834
CULTURE MEDIUM FOR ANTIMICROBIAL SUSCEP
K
84
1560
MUELLER-HINTON BROTH
K
84
0969
CULTURE MEDIA FOR ANTIMICROBIAL SUSCEP
K
84
1138
MUELLER HINTON AGAR W/BLOOD & COFACTOR
K
84
1213
ANTIMICROBIAL SUSCEPT-CULTURE MEDIA
K
84
1137
MUELLER HINTON AGAR W/WO BLOOD
K
84
0066
CHOCOLATE AGAR MUELLERH-HINTON BASE
K
83
4421
MUELLER-HINTON AGAR PLATE
K
83
3861
MUELLER HINTON AGAR
K
83
3506
PREPARED MUELLER HINTON MED/100 MM
K
83
2243
CULTURE MEDIUM FOR ANTIMICROBIAL SUS
K
83
0060
MUELLER HINTON
K
82
2119
ACCESSORY MEDIA FOR FLOW TITERTEK MIC
K
82
1607
MUELLER HINTON W/5% SHEEP'S BLOOD
K
82
1428
MUELLER HINTON CHOCOLATE MED. ENRICHED
K
82
1430
MUELLER HINTON MEDIUM
K
82
1429
MUELLER HINTON MED. W/5% SHEEP BLOOD
K
82
0846
ANTIMICROBIAL SUSCEP. TEST, MUELLER
K
82
0794
#19012 CHOCOLATE MUELLER HINTON-150X15MM
K
82
0792
#19041-150X15MM MUELLER HINTON
K
82
0793
#1904L MUELLER HINTON W/5% SHEEP BLOOD
K
81
2581
SENSI-TECT
K
81
1646
MUELLER HINTON AGAR
K
81
1608
MUELLER-HINTON
K
81
1471
MUELLER HINTON AGAR
K
81
1473
MUELLER HINTON AGAR W/5% SHEEP BLOOD
K
81
1472
MUELLER HINTON AGAR, POURED INTO A PLATE
K
81
1136
MUELLER HINTON BROTH
K
81
1049
MUELLER HINTON AGAR
K
80
2957
MUELLER HINTON BROTH
K
80
2498
MUELLER HINTON AGAR
K
80
1901
MUELLER HINTON AGAR
K
80
0987
MUELLER HINTON AGAR
K
80
0979
MUELLER HINTIN AGAR W/5% SHEEP BLOOD
K
79
2481
CULTURE PLATES & TUBED MEDIA
K
79
1413
CULTURE AND SENSITIVITY KIT
K
79
1815
MUELLER HINTON CHOCOLATE
K
79
1818
MUELLER HINTON MEDIUM W/SHEEP BLOOD
K
79
1624
MUELLER-HINTON AGAR
K
79
1485
MUELLER HINTON AGARS
K
79
0369
EMB/MUELLER-HINTON AGAR
K
78
0958
MUELLER HINTON AGAR WITH 5% SHEEP BLOOD
K
78
0959
MUELLER HINTON AGAR WITH THYMIDINE
JWY
Manual Antimicrobial Susceptibility Test Systems
LIE
Reagent/Device, Inoculum Calibration
LKA
Culture Media, Antimicrobial Susceptibility Test
LON
System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
LOP
Solution, Antimicrobial
LRG
Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems
LTT
Panels, Test, Susceptibility, Antimicrobial
LTW
Susceptibility Test Cards, Antimicrobial
LTX
Discs, Elution
MJA
Susceptibility Test Powders, Antimycobacterial
MJD
Culture Media, Antimycobacteria, Susceptibility Test
MJE
Culture Media, Antifungal, Susceptibility Test
MYI
System, Test, Genotypic Detection, Resistant Markers, Staphylococcus Colonies
NGZ
Susceptibility Test Plate, Antifungal
NIJ
System, Test, Genotypic Detection, Resistant Markers, Enterococcus Species
NQX
System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen
PMY
System, Nucleic Acid Amplification Test, Dna, Carbapenem Non-Susceptible Gram Negative Organism, Colony
POC
System, Nucleic Acid Amplification Test, Dna, Antimicrobial Resistance Marker, Direct Specimen
PRH
Positive Blood Culture Identification And Ast Kit
PTJ
Phenotypic Test Kit, Non-Susceptible/Elevated Mic Organisms, Cultured Isolates
QIV
Culture-Based Short-Term Incubation Antimicrobial Resistance Assay
QZX
Positive Blood Culture Processor For Inoculum Preparation Used For Antimicrobial Susceptibility Testing
SAN
Automated Antimicrobial Susceptibility Test System For Positive Blood Culture Samples
Subpart C—Clinical Laboratory Instruments
Subpart C—Microbiology Devices
Subpart D—Serological Reagents
Subpart F—Immunological Test Systems
Neurology
Obstetrical and Gynecological
Ophthalmic
Orthopedic
Pathology
Physical Medicine
Radiology
General and Plastic Surgery
Toxicology
Medical Genetics
Unknown
MI
/
subpart-b—diagnostic-devices
/
JTZ
/
K791815
View Source
MUELLER HINTON CHOCOLATE
Page Type
Cleared 510(K)
PDF
PDF
* The FDA doesn't provide PDFs for all submissions.
PDF
Analyzed PDF
510(k) Number
K791815
510(k) Type
Traditional
Applicant
ISLE MEDIA AND STERILE PRODUCTS, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
10/4/1979
Days to Decision
20 days