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Found 24 results
510(k) Data Aggregation
K Number
K961537Device Name
SAS SHIGELLA SONNEI FORM II ANTISERUMManufacturer
Date Cleared
1996-05-31
(39 days)
Product Code
Regulation Number
866.3660Type
TraditionalPanel
MicrobiologyReference & Predicate Devices
N/A
Why did this record match?
Product Code :
GNB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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K Number
K961528Manufacturer
Date Cleared
1996-05-20
(28 days)
Product Code
Regulation Number
866.3660Type
TraditionalPanel
MicrobiologyReference & Predicate Devices
N/A
Why did this record match?
Product Code :
GNB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
Ask a Question
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K Number
K961533Device Name
SAS SHIGELLA FLEXNERI TYPE 6 ANTISERUMManufacturer
Date Cleared
1996-05-20
(28 days)
Product Code
Regulation Number
866.3660Type
TraditionalPanel
MicrobiologyReference & Predicate Devices
N/A
Why did this record match?
Product Code :
GNB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
Ask a Question
Ask a specific question about this device
K Number
K961539Device Name
SAS SHIGELLA DYSENTERIAE TYPE 10 ANTISERUMManufacturer
Date Cleared
1996-05-20
(28 days)
Product Code
Regulation Number
866.3660Type
TraditionalPanel
MicrobiologyReference & Predicate Devices
N/A
Why did this record match?
Product Code :
GNB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
Ask a Question
Ask a specific question about this device
K Number
K961540Device Name
SAS SHIGELLA SONNEI GROUP D ANTISERUMManufacturer
Date Cleared
1996-05-20
(28 days)
Product Code
Regulation Number
866.3660Type
TraditionalPanel
MicrobiologyReference & Predicate Devices
N/A
Why did this record match?
Product Code :
GNB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
Ask a Question
Ask a specific question about this device
K Number
K961542Device Name
SAS SHIGELLA FLEXNERI TYPE 4 ANTISERUMManufacturer
Date Cleared
1996-05-20
(28 days)
Product Code
Regulation Number
866.3660Type
TraditionalPanel
MicrobiologyReference & Predicate Devices
N/A
Why did this record match?
Product Code :
GNB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
Ask a Question
Ask a specific question about this device
K Number
K961543Device Name
SAS SHIGELLA BOYDII TYPE 9 ANTISERUMManufacturer
Date Cleared
1996-05-20
(28 days)
Product Code
Regulation Number
866.3660Type
TraditionalPanel
MicrobiologyReference & Predicate Devices
N/A
Why did this record match?
Product Code :
GNB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
Ask a Question
Ask a specific question about this device
K Number
K961547Device Name
SAS SHIGELLA BOYDII TYPE 14 ANTISERUMManufacturer
Date Cleared
1996-05-20
(28 days)
Product Code
Regulation Number
866.3660Type
TraditionalPanel
MicrobiologyReference & Predicate Devices
N/A
Why did this record match?
Product Code :
GNB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
Ask a Question
Ask a specific question about this device
K Number
K961548Device Name
SAS SHIGELLA BOYDII TYPE 15 ANTISERUMManufacturer
Date Cleared
1996-05-20
(28 days)
Product Code
Regulation Number
866.3660Type
TraditionalPanel
MicrobiologyReference & Predicate Devices
N/A
Why did this record match?
Product Code :
GNB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
Ask a Question
Ask a specific question about this device
K Number
K961558Device Name
SAS SHIGELLA FLEXNERI TYPE 3 ANTISERUMManufacturer
Date Cleared
1996-05-20
(28 days)
Product Code
Regulation Number
866.3660Type
TraditionalPanel
MicrobiologyReference & Predicate Devices
N/A
Why did this record match?
Product Code :
GNB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
Ask a Question
Ask a specific question about this device
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