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Found 2 results

510(k) Data Aggregation

K Number

Device Name

Manufacturer

Date Cleared

2000-05-16

(90 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

N/A

Why did this record match?

Device Name :

C-IT

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Device Description

AI/ML Overview

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K Number

Device Name

STABLELIN ENZYME LINEARITY TEST SET C (ITEM NO. 003)

Manufacturer

SPECIALIZED ASSAYS, INC.

Date Cleared

1997-02-06

(44 days)

Product Code

Regulation Number

Type

Panel

Clinical Chemistry

Reference & Predicate Devices

N/A

Why did this record match?

Device Name :

STABLELIN ENZYME LINEARITY TEST SET C (ITEM NO. 003)

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Device Description

AI/ML Overview

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