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Found 2 results

510(k) Data Aggregation

K Number

Device Name

ACS PHENYTOIN ASSAY

Manufacturer

CIBA CORNING DIAGNOSTICS CORP.

Date Cleared

1996-03-11

(76 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

N/A

Why did this record match?

Product Code :

LGR

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Device Description

AI/ML Overview

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K Number

Device Name

INNOFLUOR PHENYTOIN ASSAY SYSTEM

Manufacturer

OXIS INTL., INC.

Date Cleared

1996-01-24

(49 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

N/A

Why did this record match?

Product Code :

LGR

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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