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Found 2 results

510(k) Data Aggregation

K Number

Device Name

HSCRP CONTROL LEVEL 1, HSCRP CONTROL LEVEL 2, AND HSCRP CONTROL LEVEL 3

Manufacturer

INTERNATIONAL ENZYMES, INC.

Date Cleared

2001-05-18

(31 days)

Product Code

Regulation Number

Type

Panel

Clinical Chemistry

Reference & Predicate Devices

N/A

Why did this record match?

Applicant Name (Manufacturer) :

INTERNATIONAL ENZYMES, INC.

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Device Description

AI/ML Overview

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Ask a specific question about this device

K Number

Device Name

LIQUID IMMUNOLOGY CONTROL LEVEL I, II, III

Manufacturer

INTERNATIONAL ENZYMES, INC.

Date Cleared

1996-08-20

(12 days)

Product Code

Regulation Number

Type

Panel

Clinical Chemistry

Reference & Predicate Devices

N/A

Why did this record match?

Applicant Name (Manufacturer) :

INTERNATIONAL ENZYMES, INC.

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Device Description

AI/ML Overview

Ask a Question

Ask a specific question about this device

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