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Found 2 results

510(k) Data Aggregation

K Number

Validate with FDA (Live)

Device Name

QUALITROL DHP IMMUNOASSAY CONTROL, LEVELS 1,2, AND 3

Manufacturer

CONSOLIDATED TECHNOLOGIES OF WISCONSIN

Date Cleared

2000-11-02

(204 days)

Product Code

Regulation Number

Type

Panel

Clinical Chemistry

Age Range

N/A

Reference & Predicate Devices

N/A

Predicate For

N/A

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Device Description

AI/ML Overview

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Ask a specific question about this device

K Number

Validate with FDA (Live)

Device Name

QUALITROL LIPID CONTROL, LEVELS 1 AND 2

Manufacturer

CONSOLIDATED TECHNOLOGIES OF WISCONSIN

Date Cleared

2000-04-13

(31 days)

Product Code

Regulation Number

Type

Panel

Clinical Chemistry

Age Range

N/A

Reference & Predicate Devices

N/A

Predicate For

N/A

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Device Description

AI/ML Overview

Ask a Question

Ask a specific question about this device

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