FDA 510(k) Applications Submitted by MICHAEL LINSS
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K040449 |
02/20/2004 |
VARELISA B2 GLYCOPROTEIN I IGG ANTIBODIES, MODELS 18748 AND 18796 |
PHARMACIA DEUTSCHLAND GMBH |
| K040450 |
02/20/2004 |
VARELISA B2 GLYCOPROTEIN I IGA ANTIBODIES, MODELS 18948 AND 18996 |
PHARMACIA DEUTSCHLAND GMBH |
| K040451 |
02/20/2004 |
VARELISA B2 GLYCOPROTEIN I IGM ANTIBODIES, MODELS 18848 AND 18896 |
PHARMACIA DEUTSCHLAND GMBH |
| K040452 |
02/20/2004 |
VARELISA B2 GLYCOPROTEIN I ANTIBODIES SCREEN, MODELS 19048 AND 19096 |
PHARMACIA DEUTSCHLAND GMBH |
| K020752 |
03/07/2002 |
VARELISA CARDIOLIPIN IGG ANTIBODIES, MODELS 15548 & 15596 |
PHARMACIA DEUTSCHLAND GMBH |
| K020757 |
03/07/2002 |
VARELISA CARDIOLIPIN IGA ANTIBODIES, MODELS 15748 & 15796 |
PHARMACIA DEUTSCHLAND GMBH |
| K040810 |
03/29/2004 |
VARELISA HISTONE ANTIBODIES, MODEL 16496 |
PHARMACIA DEUTSCHLAND GMBH |
| K040811 |
03/29/2004 |
VARELISA SSDNA ANTIBODIES, MODEL 14896 |
PHARMACIA DEUTSCHLAND GMBH |
| K050967 |
04/18/2005 |
VARELISA RECOMBI CTD SCREEN, MODEL 13096 |
SWEDEN DIAGNOSTICS (GERMANY) GMBH |
| K041040 |
04/22/2004 |
VARELISA MPO ANCA, MODEL 17648/17696 |
SWEDEN DIAGNOSTICS (GERMANY) GMBH |
| K041043 |
04/22/2004 |
VARELISA PR3 ANCA, MODEL NUMBER 17748/17796 |
PHARMACIA DEUTSCHLAND GMBH |
| K041173 |
05/05/2004 |
CELIKEY IGG ITG IGG ANTIBODIES, MODEL 17996 |
SWEDEN DIAGNOSTICS (GERMANY) GMBH |
| K041174 |
05/05/2004 |
CELIKEY TTG (HUMAN, RECOMBINANT) IGA ANTIBODIES MODEL #18148/18196 |
SWEDEN DIAGNOSTICS (GERMANY) GMBH |
| K041354 |
05/20/2004 |
VARELISA GLIADIN IGA ANTIBODIES MODEL #19848/19896 |
SWEDEN DIAGNOSTICS (GERMANY) GMBH |
| K041357 |
05/20/2004 |
VARELISA GLIADIN IGG ANTIBODIES |
SWEDEN DIAGNOSTICS (GERMANY) GMBH |
| K023433 |
10/15/2002 |
VARELISA CARDIOLIPIN ANTIBODIES SCREEN, MODELS 15848 AND 15896 |
PHARMACIA DIAGNOSTICS GMBH & CO. KG |
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