FDA 510(k) Applications Submitted by KAREN MATIS
FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
K000312 |
02/01/2000 |
VARELISA SM ANTIBODIES |
PHARMACIA & UPJOHN CO. |
K122400 |
08/07/2012 |
CARDIOX FLOW DETECTION SYSTEM |
CARDIOX CORP. |
K000132 |
01/18/2000 |
ALLERGEN IMMUNOCAP, MODELS C74, E89, EX2, EX70, EX71, EX73, FX8, FX9, FX10, FX16, FX73, I72, I75, I76, K71, K73, K81, K8 |
PHARMACIA & UPJOHN CO. |
K970420 |
02/03/1997 |
MASTERCAP AM 5.0/MASTERCAP RM 5.0 |
PHARMACIA, INC. |
K991048 |
03/30/1999 |
ALLERGEN IMMUNOCAP, MODELS E7, F93, F94, F95, F203, F204, F208, F209, F210, F214, F216, F235, F237, F242, F255, F259, F2 |
PHARMACIA & UPJOHN CO. |
K981559 |
05/01/1998 |
UNICAP THYROGLOBULIN IGG ASSAY, UNICAP THYROID PEROXIDASE IGG ASSAY |
PHARMACIA & UPJOHN CO. |
K981930 |
05/01/1998 |
UNICAP THYROID PEROXIDASE IGG |
PHARMACIA & UPJOHN CO. |
K972068 |
06/03/1997 |
UNICAP SPECIFIC IGE FEIA ASSAY, LATEX ALLERGEN IMMUNOCAP K82 |
PHARMACIA, INC. |
K991945 |
06/09/1999 |
PHARMACIA CAP SYSTEM IGE FEIA, MODEL 10-9395-01 |
PHARMACIA & UPJOHN CO. |
K962274 |
06/13/1996 |
UNICAP 100 |
PHARMACIA, INC. |
K982343 |
07/06/1998 |
ALLERGEN IMMUNOCAP MODELS D73, D74, E71, E72, E73, E74 E75, E76,E82,E88, F48, F90, F92, F96, F201, F215, M70, T17, T72,3 |
PHARMACIA & UPJOHN CO. |
K982533 |
07/20/1998 |
UNICAP GLIADIN IGA ASSAY |
PHARMACIA & UPJOHN CO. |
K993108 |
09/17/1999 |
VARELISA RECOMBI ANA SCREEN EIA, MODELS 128 48/ 128 96 |
PHARMACIA & UPJOHN CO. |
K993109 |
09/17/1999 |
VARELISA RECOMBI ANA PROFILE |
PHARMACIA & UPJOHN CO. |
K993388 |
10/08/1999 |
ALLERGEN IMMUNDOCAP MODELC5, C6, C73, E201, E213, F50, F51,F54, F55, F56, F57, F58, F59, F60, F61, F205, F213, F218, F |
PHARMACIA & UPJOHN CO. |
K964152 |
10/16/1996 |
UNICAP TOTAL IGE ASSAY/PHARMACIA TOTAL IGE CONTROLS LMH |
PHARMACIA, INC. |
K993585 |
10/22/1999 |
VARELISA TPO ANTIBODIES, MODEL 12348/12396 |
PHARMACIA & UPJOHN CO. |
K993589 |
10/22/1999 |
VARELISA RNP ANTIBODIES |
PHARMACIA & UPJOHN CO. |
K003414 |
11/02/2000 |
VARELISA TG (THYROGLOBULIN) ANTIBODIES, |
PHARMACIA & UPJOHN CO. |
K974350 |
11/19/1997 |
ALLERGAN IMMUNO CAP M4, M8, K70 |
PHARMACIA, INC. |
K974580 |
12/08/1997 |
ALLERGEN IMMUNOCAP F256,F245,F207,F202 |
PHARMACIA & UPJOHN CO. |
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