FDA 510(k) Search

Search Filters

Search Everything

510k Number

Type

Panel

Product Code

Subsequent Product Code

Applicant Name (Manufacturer)

Device Name

Device Description

Intended Use

Predicate Devices

Reference Devices

Pediatric Age Range

Regulation Number

510k Summary Text (Full-text Search)

Decision

Decision Date From

Decision Date To

Third Party Reviewed

Expedited Review

Is SaMD

Contains AI/ML

Is IVD

Is Diagnostic

Is Therapeutic

Is Pediatric

is PCCP Authorized

Has PDF Data

Sort By

Sort Order

Search Results

Found 3 results

510(k) Data Aggregation

K Number

Validate with FDA (Live)

Device Name

ELIAS ANA-HEP-2

Manufacturer

ELIAS USA, INC.

Date Cleared

1997-03-06

(122 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

VARELISA ANA (4) PROFILE

Manufacturer

ELIAS USA, INC.

Date Cleared

1996-09-30

(40 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

VARELISA HELICOBACTER PYLORI ANTIBODIES

Manufacturer

ELIAS USA, INC.

Date Cleared

1996-08-30

(379 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

Page 1 of 1