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Found 3 results

510(k) Data Aggregation

K Number

Validate with FDA (Live)

Device Name

PROLONG, MODELS PL50, PL100, PL150

Manufacturer

LIFE-TECH INTL., INC.

Date Cleared

2000-07-06

(90 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

Manufacturer

LIFE-TECH INTL., INC.

Date Cleared

1996-12-10

(439 days)

Product Code

Regulation Number

Type

Panel

Age Range

N/A

Reference & Predicate Devices

N/A

Predicate For

K102084,K162048,K972001

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

Manufacturer

LIFE-TECH INTL., INC.

Date Cleared

1996-12-10

(404 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

Ask a Question

Ask a specific question about this device

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