Medical Device Manufacturer · US , Westervillle , OH

Pharmacia & Upjohn Co. - FDA 510(k) Cleared Devices

18 submissions · 18 cleared · Since 1996

18

Total

18

Cleared

0

Denied

FDA 510(k) Regulatory Record - Pharmacia & Upjohn Co. Immunology ✕

17 devices

1-12 of 17

Cleared Nov 27, 2000

VARELISA TG (THYROGLOBULIN) ANTIBODIES,

Immunology · 25d

Cleared Mar 17, 2000

VARELISA SM ANTIBODIES

Immunology · 45d

Cleared Feb 18, 2000

ALLERGEN IMMUNOCAP, MODELS C74, E89, EX2, EX70, EX71, EX73, FX8, FX9, FX10,...

Immunology · 31d

Cleared Jan 05, 2000

VARELISA TPO ANTIBODIES, MODEL 12348/12396

Immunology · 75d

Cleared Dec 01, 1999

ALLERGEN IMMUNDOCAP MODELC5, C6, C73, E201, E213, F50, F51,F54, F55, F56,...

Immunology · 54d

Cleared Nov 26, 1999

VARELISA RNP ANTIBODIES

Immunology · 35d

Cleared Nov 12, 1999

VARELISA RECOMBI ANA SCREEN EIA, MODELS 128 48/ 128 96

Immunology · 56d

Cleared Nov 12, 1999

VARELISA RECOMBI ANA PROFILE

Immunology · 56d

Cleared Jul 28, 1999

PHARMACIA CAP SYSTEM IGE FEIA, MODEL 10-9395-01

Immunology · 49d

Cleared May 14, 1999

ALLERGEN IMMUNOCAP, MODELS E7, F93, F94, F95, F203, F204, F208, F209, F210,...

Immunology · 45d

Cleared Oct 22, 1998

UNICAP GLIADIN IGA ASSAY

Immunology · 94d

Cleared Oct 22, 1998

UNICAP GLIADIN IGG ASSAY

Immunology · 94d