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Found 2 results

510(k) Data Aggregation

K Number

Validate with FDA (Live)

Device Name

PALFIQUE ESTELITE LV CLEAR

Manufacturer

TOKUYAMA AMERICA, INC.

Date Cleared

2001-02-27

(29 days)

Product Code

Regulation Number

Type

Panel

Age Range

N/A

Reference & Predicate Devices

N/A

Predicate For

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Device Description

AI/ML Overview

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K Number

Validate with FDA (Live)

Device Name

PALFIQUE ESTELITE LV

Manufacturer

TOKUYAMA AMERICA, INC.

Date Cleared

2001-01-04

(113 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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