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510(k) Data Aggregation

K Number

Device Name

VITROS IMMUNODIAGNOSTICS PRODUCTS/TSH REAGENT PACK (GEM. 1001)/TSH CALIBRATORS(GEM.C001)

Manufacturer

JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC.

Date Cleared

1996-12-16

(33 days)

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Panel

Clinical Chemistry

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N/A

Why did this record match?

Device Name :

VITROS IMMUNODIAGNOSTICS PRODUCTS/TSH REAGENT PACK (GEM. 1001)/TSH CALIBRATORS(GEM.C001)

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Device Description

AI/ML Overview

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