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Found 2 results

510(k) Data Aggregation

K Number

Device Name

ACCULINE PREGNANCY TEST

Manufacturer

GENIX BIOTEK, INC.

Date Cleared

1997-04-25

(29 days)

Product Code

Regulation Number

Why did this record match?

Applicant Name (Manufacturer) :

GENIX BIOTEK, INC.

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty

Intended Use

Device Description

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K Number

Device Name

ACCUPACK PREGNANCY TEST

Manufacturer

GENIX BIOTEK, INC.

Date Cleared

1997-02-20

(93 days)

Product Code

Regulation Number

Why did this record match?

Applicant Name (Manufacturer) :

GENIX BIOTEK, INC.

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty

Intended Use

Device Description

Ask a Question

Ask a specific question about this device

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