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Found 6 results
510(k) Data Aggregation
K Number
K971120Device Name
DISPENS-O-DISC (TM) LEVOFLOXACINManufacturer
Date Cleared
1997-04-14
(18 days)
Product Code
Regulation Number
866.1620Type
TraditionalPanel
MicrobiologyReference & Predicate Devices
N/A
Why did this record match?
Applicant Name (Manufacturer) :
DIFCO LABORATORIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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K Number
K971211Device Name
DISPENS-O-DISC SPARFLOXACINManufacturer
Date Cleared
1997-04-14
(18 days)
Product Code
Regulation Number
866.1620Type
TraditionalPanel
MicrobiologyReference & Predicate Devices
N/A
Why did this record match?
Applicant Name (Manufacturer) :
DIFCO LABORATORIES, INC.
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
K963508Device Name
DISPENS-O-DISC MEROPENEMManufacturer
Date Cleared
1996-09-26
(23 days)
Product Code
Regulation Number
866.1620Type
TraditionalPanel
MicrobiologyReference & Predicate Devices
N/A
Why did this record match?
Applicant Name (Manufacturer) :
DIFCO LABORATORIES, INC.
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
K961148Device Name
CEFEPIME DISPANS-O-DISC (CEFEPLIME - 30MCG)Manufacturer
Date Cleared
1996-04-26
(36 days)
Product Code
Regulation Number
866.2900Type
TraditionalPanel
MicrobiologyReference & Predicate Devices
N/A
Why did this record match?
Applicant Name (Manufacturer) :
DIFCO LABORATORIES, INC.
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
K954783Device Name
DRYSLIDE CARTARRHALISManufacturer
Date Cleared
1996-02-06
(112 days)
Product Code
Regulation Number
866.2660Type
TraditionalPanel
MicrobiologyReference & Predicate Devices
N/A
Why did this record match?
Applicant Name (Manufacturer) :
DIFCO LABORATORIES, INC.
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
K954784Device Name
DRYSIDE NEISSERIAManufacturer
Date Cleared
1996-01-30
(105 days)
Product Code
Regulation Number
866.2660Type
TraditionalPanel
MicrobiologyReference & Predicate Devices
N/A
Why did this record match?
Applicant Name (Manufacturer) :
DIFCO LABORATORIES, INC.
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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