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Found 3 results

510(k) Data Aggregation

K Number

Validate with FDA (Live)

Device Name

ABUSCREEN ONLINE LSD REAGENT (90 ML TEST KIT)

Manufacturer

ROCHE DIAGNOSTIC SYSTEMS, INC.

Date Cleared

1996-06-21

(67 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

N/A

Predicate For

N/A

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Device Description

AI/ML Overview

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K Number

Validate with FDA (Live)

Device Name

EMIT II LSD ASSAY, EMIT LSD CALIBRATORS & EMIT LSD CONTROLS

Manufacturer

BEHRING DIAGNOSTICS, INC.

Date Cleared

1996-02-23

(86 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

N/A

Predicate For

N/A

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Device Description

AI/ML Overview

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K Number

Validate with FDA (Live)

Device Name

CEDIA DAU LSD ASSAY

Manufacturer

MICROGENICS CORP.

Date Cleared

1996-02-09

(45 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

N/A

Predicate For

N/A

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Device Description

AI/ML Overview

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