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Found 3 results

510(k) Data Aggregation

K Number

Device Name

LACTATE DEHYDROGENASE (LD)

Manufacturer

RANDOX LABORATORIES, LTD.

Date Cleared

1997-05-07

(72 days)

Product Code

Regulation Number

Type

Panel

Clinical Chemistry

Reference & Predicate Devices

N/A

Predicate For

N/A

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Device Description

AI/ML Overview

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K Number

Device Name

LACTATE DEHYDROGENASE

Manufacturer

DERMA MEDIA LAB., INC.

Date Cleared

1997-01-09

(31 days)

Product Code

Regulation Number

Type

Panel

Clinical Chemistry

Reference & Predicate Devices

N/A

Predicate For

N/A

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Device Description

AI/ML Overview

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K Number

Device Name

LACTATE DEHYDROGENASE REAGENT SET

Manufacturer

POINTE SCIENTIFIC, INC.

Date Cleared

1996-06-03

(49 days)

Product Code

Regulation Number

Type

Panel

Clinical Chemistry

Reference & Predicate Devices

N/A

Predicate For

N/A

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Device Description

AI/ML Overview

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