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Found 3 results

510(k) Data Aggregation

K Number

Device Name

ELIAS ANA-HEP-2

Manufacturer

ELIAS USA, INC.

Date Cleared

1997-03-06

(122 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

N/A

Why did this record match?

Applicant Name (Manufacturer) :

ELIAS USA, INC.

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Device Description

AI/ML Overview

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Ask a specific question about this device

K Number

Device Name

VARELISA ANA (4) PROFILE

Manufacturer

ELIAS USA, INC.

Date Cleared

1996-09-30

(40 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

N/A

Why did this record match?

Applicant Name (Manufacturer) :

ELIAS USA, INC.

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

K Number

Device Name

VARELISA HELICOBACTER PYLORI ANTIBODIES

Manufacturer

ELIAS USA, INC.

Date Cleared

1996-08-30

(379 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

N/A

Why did this record match?

Applicant Name (Manufacturer) :

ELIAS USA, INC.

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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