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510(k) Data Aggregation
K Number
K953672Manufacturer
Date Cleared
1996-07-01
(329 days)
Product Code
Regulation Number
862.1510Type
TraditionalPanel
Clinical ChemistryReference & Predicate Devices
N/A
Why did this record match?
Applicant Name (Manufacturer) :
POLYMER TECHNOLOGY INTL.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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K Number
K953662Device Name
FIRST CHOICE KETONES URINE TEST STRIPSManufacturer
Date Cleared
1996-06-14
(312 days)
Product Code
Regulation Number
862.1435Type
TraditionalPanel
Clinical ChemistryReference & Predicate Devices
N/A
Why did this record match?
Applicant Name (Manufacturer) :
POLYMER TECHNOLOGY INTL.
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
K953661Device Name
FIRST CHOICE GLUCOSE URINE TEST STRIPSManufacturer
Date Cleared
1996-06-14
(312 days)
Product Code
Regulation Number
862.1340Type
TraditionalPanel
Clinical ChemistryReference & Predicate Devices
N/A
Why did this record match?
Applicant Name (Manufacturer) :
POLYMER TECHNOLOGY INTL.
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
K953680Manufacturer
Date Cleared
1996-06-12
(310 days)
Product Code
Regulation Number
862.1435Type
TraditionalPanel
Clinical ChemistryReference & Predicate Devices
N/A
Why did this record match?
Applicant Name (Manufacturer) :
POLYMER TECHNOLOGY INTL.
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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