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Found 4 results

510(k) Data Aggregation

K Number

Validate with FDA (Live)

Device Name

SENSITITRE 18 HOUR SUSCEPTIBILITY PLATES

Manufacturer

SENSITITRE ALAMAR

Date Cleared

1996-09-30

(69 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

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Ask a specific question about this device

K Number

Validate with FDA (Live)

Device Name

SENSITITRE 18 HOUR SUSCEPTIBILITY PLATES

Manufacturer

ACCUMED INTL., INC.

Date Cleared

1996-04-09

(75 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

K Number

Validate with FDA (Live)

Device Name

SENSITITRE 18 HOUR SUSCEPTIBILITY PLATES

Manufacturer

ACCUMED INTL., INC.

Date Cleared

1996-03-27

(70 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

K Number

Validate with FDA (Live)

Device Name

SENSITITRE 18 HOUR SUSCEPTIBILITY PLATES

Manufacturer

SENSITITRE LTD.

Date Cleared

1996-03-11

(55 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

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