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510(k) Data Aggregation

K Number

Device Name

ACCUSIGN DOA 3/DOA 3 (BZO/BAR/PCP), BZO/BAR/PCP, BIOSIGN DOA 3/BZO/BAR/PCP, BIOSIGN BZO/BAR/PCP

Manufacturer

PRINCETON BIOMEDITECH CORP.

Date Cleared

1996-06-12

(65 days)

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Regulation Number

Type

Panel

Reference & Predicate Devices

N/A

Why did this record match?

Device Name :

ACCUSIGN DOA 3/DOA 3 (BZO/BAR/PCP), BZO/BAR/PCP, BIOSIGN DOA 3/BZO/BAR/PCP, BIOSIGN BZO/BAR/PCP

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

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AI/ML Overview

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