Medical Device Manufacturer · DE , Freiburg

Pharmacia Deutschland GmbH

10 submissions · 10 cleared · Since 2002
10
Total
10
Cleared
0
Denied

Pharmacia Deutschland GmbH — FDA 510(k) Submissions

Pharmacia Deutschland GmbH has submitted 10 FDA 510(k) premarket notifications since 2002, of which 10 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include System,test,antibodies,b2 - Glycoprotein I (b2 - Gpi), System, Test, Anticardiolipin Immunological, Antinuclear Antibody (enzyme-labeled), Antigen, Controls, Anti-dna Antibody (enzyme-labeled), Antigen, Control, Test System, Antineutrophil Cytoplasmic Antibodies (anca) . Use the specialty filter in the sidebar to narrow results.

10 devices
1–10 of 10
VARELISA PR3 ANCA, MODEL NUMBER 17748/17796
K041043 · MOB Test System,... · Immunology
Jul 2004 71d
VARELISA HISTONE ANTIBODIES, MODEL 16496
K040810 · LJM Antinuclear Antibody... · Immunology
May 2004 46d
VARELISA SSDNA ANTIBODIES, MODEL 14896
K040811 · LRM Anti-dna Antibody... · Immunology
May 2004 45d
VARELISA B2 GLYCOPROTEIN I IGG ANTIBODIES, MODELS 18748 AND 18796
K040449 · MSV System,test,antibodies,b2... · Immunology
May 2004 81d
VARELISA B2 GLYCOPROTEIN I IGA ANTIBODIES, MODELS 18948 AND 18996
K040450 · MSV System,test,antibodies,b2... · Immunology
May 2004 81d
VARELISA B2 GLYCOPROTEIN I IGM ANTIBODIES, MODELS 18848 AND 18896
K040451 · MSV System,test,antibodies,b2... · Immunology
May 2004 81d
VARELISA B2 GLYCOPROTEIN I ANTIBODIES SCREEN, MODELS 19048 AND 19096
K040452 · MSV System,test,antibodies,b2... · Immunology
May 2004 81d
VARELISA CARDIOLIPIN IGG ANTIBODIES, MODELS 15548 & 15596
K020752 · MID System, Test,... · Immunology
May 2002 56d
VARELISA CARDIOLIPIN IGA ANTIBODIES, MODELS 15748 & 15796
K020757 · MID System, Test,... · Immunology
May 2002 56d
VARELISA CARDIOLIPIN IGM ANTIBODIES, MODELS 15648 & 15696
K020758 · MID System, Test,... · Immunology
May 2002 56d
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