Medical Device Manufacturer · US , Osceola , WI

Elias U.S.A., Inc. - FDA 510(k) Cleared Devices

54 submissions · 54 cleared · Since 1992

54

Total

54

Cleared

0

Denied

FDA 510(k) Regulatory Record - Elias U.S.A., Inc. Immunology ✕

49 devices

1-12 of 49

Cleared Mar 06, 1997

ELIAS ANA-HEP-2

Immunology · 122d

Cleared Sep 30, 1996

VARELISA ANA (4) PROFILE

Immunology · 40d

Cleared Jan 26, 1996

VARELISA PR3-ANCA

Immunology · 178d

Cleared Jan 26, 1996

VARELISA MPO-ANCA

Immunology · 178d

Cleared Oct 02, 1995

VARELISA CARDIOLIPIN ABS SCREEN

Immunology · 200d

Cleared Apr 17, 1995

VARELISA COMBINED DNA ANTIBODIES EIA

Immunology · 223d

Cleared Apr 17, 1995

VARELISA ANA-4 SCREEN

Immunology · 32d

Cleared Apr 17, 1995

VARELISA ANA PROFILE

Immunology · 31d

Cleared Apr 17, 1995

VARELISA PARIETAL CELL ANTIBODIES

Immunology · 31d

Cleared Apr 17, 1995

VARELISA HISTONE ANTIBODIES

Immunology · 31d

Cleared Mar 10, 1995

VARELISA DSDNA ANTIBODIES (FARR VERSION)

Immunology · 65d

Cleared Jan 24, 1995

VARELISA M2 ANTIBODIES

Immunology · 70d

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