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Found 4 results

510(k) Data Aggregation

K Number

Validate with FDA (Live)

Device Name

WAKO AUTOKIT LP(A) AND LP(A) CALIBRATOR/COBAS FARA

Manufacturer

WAKO CHEMICALS, USA, INC.

Date Cleared

2000-07-24

(28 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

K Number

Validate with FDA (Live)

Device Name

WAKO AUTOKIT LP(A) & LP(A) CALIBRATOR/AEROSET

Manufacturer

WAKO CHEMICALS, USA, INC.

Date Cleared

2000-07-24

(28 days)

Product Code

Regulation Number

Type

Panel

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

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K Number

Validate with FDA (Live)

Device Name

WAKO AUTOKIT LP(A) & LP(A) CALIBRATOR/BECKMAN CX

Manufacturer

WAKO CHEMICALS, USA, INC.

Date Cleared

2000-07-24

(28 days)

Product Code

Regulation Number

Type

Panel

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

K Number

Validate with FDA (Live)

Device Name

WAKO AUTOKIT LP(A) & LP(A) CALIBRATOR/COBAS BIO

Manufacturer

WAKO CHEMICALS, USA, INC.

Date Cleared

2000-07-24

(28 days)

Product Code

Regulation Number

Type

Panel

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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