Medical Device Manufacturer · US , East Walpole , MA

Ciba Corning Diagnostics Corp. - FDA 510(k) Cleared Devices

125 submissions · 125 cleared · Since 1986

125

Total

125

Cleared

0

Denied

FDA 510(k) Regulatory Record - Ciba Corning Diagnostics Corp. Immunology ✕

13 devices

1-13 of 13

Cleared Apr 21, 1994

MAGIC LITE SQ SPECIFIC IGE IMMUNOASSAY SYSTEM

Immunology · 209d

Cleared Feb 23, 1993

CIBA CORNING MAGIC LITE SQ SPECIFIC IGE ASSAY

Immunology · 225d

Cleared Aug 20, 1992

MAGIC LITE SQ SPECIFIC IGE IMMUNOASSAY SYSTEM

Immunology · 289d

Cleared Apr 08, 1992

ACS TOTAL IGE IMMUNOASSAY

Immunology · 71d

Cleared Jul 31, 1991

MAGIC LITE SQ SPECIFIC IGE IMMUNOASSAY SYSTEM

Immunology · 49d

Cleared Mar 22, 1991

CIBA CORNING MODEL 980 MAGIC LITE ALLERGY MANAGER

Immunology · 134d

Cleared Mar 12, 1991

CIBA CORNING ACS FERRITIN IMMUNOASSAY

Immunology · 75d

Cleared Nov 21, 1990

Immunology · 100d

Cleared Dec 04, 1989

CIBA CORNING MAGIC LITE SQ SPECIFIC IGE ASSAY

Immunology · 13d

Cleared Oct 27, 1988

CIBA CORNING MAGIC LITE TOTAL IGE IMMUNOASSAY

Immunology · 23d

Cleared Oct 07, 1987

CIBA CORNING MAGIC LITE FERRITIN

Immunology · 35d

Cleared Sep 21, 1987

TRI-LEVEL LIGAND CONTROL

Immunology · 25d

Cleared May 21, 1987

TRI-LEVEL LIGAND CONTROL

Immunology · 160d