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Innolitics
Anesthesiology
Review Panel
Cardiovascular
Review Panel
Chemistry
Review Panel
Dental
Review Panel
Ear, Nose, Throat
Review Panel
Gastroenterology and Urology
Review Panel
General Hospital
Review Panel
Hematology
Review Panel
Immunology
Review Panel
Microbiology
Review Panel
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)
Show All 74 Submissions
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
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
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 30 May 2025 at 11:05 pm
MI
/
subpart-b—diagnostic-devices
/
JTZ
/
K963036
View Source
MUELLER HINTON II BROTH (CATION-ADJUSTED) WITH LYSED HORSE BLOOD
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K963036
510(k) Type
Traditional
Applicant
BECTON DICKINSON MICROBIOLOGY SYSTEMS
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
10/7/1996
Days to Decision
63 days
Submission Type
Summary
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.)
Show All 74 Submissions
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
PTJ
Phenotypic Test Kit, Non-Susceptible/Elevated Mic Organisms, Cultured Isolates
QIV
Culture-Based Short-Term Incubation Antimicrobial Resistance Assay
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
/
K963036
View Source
MUELLER HINTON II BROTH (CATION-ADJUSTED) WITH LYSED HORSE BLOOD
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K963036
510(k) Type
Traditional
Applicant
BECTON DICKINSON MICROBIOLOGY SYSTEMS
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
10/7/1996
Days to Decision
63 days
Submission Type
Summary