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510(k) Data Aggregation

K Number

Device Name

BIOCHECK, INC. B-2 MICROGLOBIN ENZYME IMMUNOASAY TEST KIT, MODEL BC-1061

Manufacturer

Date Cleared

2000-09-26

(180 days)

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Regulation Number

Type

Panel

Reference & Predicate Devices

N/A

Why did this record match?

Device Name :

BIOCHECK, INC. B-2 MICROGLOBIN ENZYME IMMUNOASAY TEST KIT, MODEL BC-1061

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Device Description

AI/ML Overview

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