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510(k) Data Aggregation

K Number

Device Name

BIODATA SR1 FAH-HCG ENZYME IMMUNOASSAY KIT

Manufacturer

BIOCHEM IMMUNOSYSTEMS (U.S.), INC.

Date Cleared

1996-07-10

(315 days)

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Regulation Number

Type

Panel

Clinical Chemistry

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N/A

Why did this record match?

Device Name :

BIODATA SR1 FAH-HCG ENZYME IMMUNOASSAY KIT

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Device Description

AI/ML Overview

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