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Found 2 results

510(k) Data Aggregation

K Number

Device Name

PROCLUDE-SENSITIVE

Manufacturer

ORTEK THERAPEUTICS, INC.

Date Cleared

2001-02-01

(84 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

N/A

Why did this record match?

Device Name :

PROCLUDE-SENSITIVE

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Device Description

AI/ML Overview

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K Number

Device Name

Manufacturer

ORTEK THERAPEUTICS, INC.

Date Cleared

2000-12-14

(80 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

N/A

Why did this record match?

Device Name :

PROCLUDE

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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