FDA 510(k) Applications Submitted by MARTIN MANN
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| DEN120001 |
01/12/2012 |
IMMUNOCAP TRYPTASE, CALIBRATORS, CURVE CONTROL, CONJUGATE 50, CALIBRATOR STRIP, CURVE CONTROL STRIP, ANTI-TRYPTASE |
PHADIA US INC. |
| K140225 |
01/29/2014 |
ELIA PR3S IMMUNOASSAY, ELIA MPOS IMMUNOASSAY, ELIA GBM IMMUNOASSAY, ELIA ANCA/GBM POSITIVE CONTROL 100, ELIA ANCA/GBM PO |
PHADIA US INC. |
| K100999 |
04/12/2010 |
IMMUNOCAP ALLERGEN F20, ALMOND MODEL: 14-4179-01 |
PHADIA AB |
| K121156 |
04/16/2012 |
AUTOMATED IN VITRO QUANTITATIVE ASSAY FOR THE MEASUREMENT OF ALLERGEN SPECIFIC IGE ANTIBODIES |
PHADIA AB |
| K231151 |
04/24/2023 |
Kenota 1 Total IgE; Kenota 1 (instrument) |
Kenota Inc. |
| K101251 |
05/04/2010 |
IMMUNOCAP ALLERGEN D202, ALLERGEN COMPONENT NDER P 1, HOUSE DUST MITE, IMMUNOCAP ALLERGEN D203, ALLERGEN |
PHADIA AB |
| K121463 |
05/17/2012 |
IMMUNOCAP ALLERGEN K82 |
Thermo Fisher Scientific |
| K081830 |
06/30/2008 |
IMMUNOCAP RAPID INHALANT PROFILE , IMMUNOCAP RAPID READER, IMMUNOCAP RAPID READER CHECK DEVICE, AND IMMUNOCAP RAPID QC1 |
PHADIA AB |
| K092050 |
07/07/2009 |
IMMUNOCAP ALLERGEN D201, HOUSE DUST MITE, MODEL 4-4896-01 |
PHADIA AB |
| K111919 |
07/07/2011 |
IMMUNOCAP SPECIFIC IGE ALLERGEN BUNDLE, 12 ALLERGEN COMPONENTS |
PHADIA US INC. |
| K122197 |
07/24/2012 |
AUTOMATED IN VITRO QUANTITATIVE ASSAY FOR THE MEASUREMENT OF ALLERGEN SPECIFIC IGE ANTIBODIES |
PHADIA US INC. |
| K072149 |
08/03/2007 |
ELIA SYMPHONY IMMUNOASSAY, ANA CONTROL, MODEL 14-55508-01,83-1004-01 |
PHADIA US INC. |
| K092978 |
09/28/2009 |
IMMUNOCAP RAPID READER, MODEL 12-3600-10 |
PHADIA US INC. |
| K123275 |
10/19/2012 |
IMMUNOCAP ALLERGEN i3, COMMON WASP VENOM (YELLOW JACKET), AND IMMUNOCAP ALLERGEN i4, PAPER WASP VENOM |
PHADIA AB |
| K113841 |
12/28/2011 |
IMMUNOCAP ALLERGEN COMPONENTS BUNDLE |
PHADIA US INC. |
| K122139 |
07/19/2012 |
SMITH & NEPHEW R3 CONSTRAINED LINERS |
SMITH & NEPHEW, INC. |
| K132296 |
07/23/2013 |
D-RAD SMART PACK |
SMITH & NEPHEW, INC. |
| K142520 |
09/08/2014 |
Smith & Nephew, Inc. Spatialframe.com V5.0 Web-based software |
Smith & Nephew, Inc |
| K123159 |
10/09/2012 |
SMITH & NEWPHEW, INC. DISPOSABLE KNEE INSTRUMENTS |
SMITH & NEPHEW, INC. |
| K112414 |
08/22/2011 |
ELIA B2-GLYCOPROTEIN I IGA IMMUNOASSAY |
PHADIA US INC. |
| K132631 |
08/22/2013 |
EIA SMDP IMMUNOASSAY |
PHADIA US INC. |
| K083117 |
10/22/2008 |
ELIA RNP70 IMMUNOASSAY, ELIA SCI-70 IMMUNOASSAY AND ELIA JO-1 IMMUNOASSAY, MODELS 14-5511-01, 14-5506-01 AND 14-5507-01 |
PHADIA US INC. |
| K093459 |
11/06/2009 |
ELIA GLIADIN DP IGA IMMUNOASSAY AND ELIA GLIADIN DP IGG IMMUNOASSAY, MODELS 14-5538-01, 14-5539-01 |
PHADIA US INC. |
| K200132 |
01/21/2020 |
Ashvins |
MedicalCommunications GmbH |
| K191075 |
04/23/2019 |
Healy |
TimeWaver Production GmbH |
| K102673 |
09/16/2010 |
RHEUMATOID FACTOR IMMUNOLOGICAL TEST SYSTEM |
PHADIA US INC. |
| K140493 |
02/27/2014 |
ELIA SCL-70S IMMUNOASSAY |
PHADIA GMBH |
| K061165 |
04/26/2006 |
ELIA CCP, MODEL 14-5515-01; ELIA CCP CONTROL, MODEL 83-1009-01 |
SWEDEN DIAGNOSTICS (US), INC. |
| K051218 |
05/12/2005 |
MODIFICATION TO: UNICAP SPECIFIC IGE |
PHARMACIA DIAGNOSTICS AB |
| K131821 |
06/20/2013 |
ELIA(TM) CARDIOLIPIN IGA IMMUNOASSAY |
PHADIA US INC. |
| K072393 |
08/27/2007 |
ELIA DSDNA IMMUNOASSAY, MODEL 14-5500-01, ELIA ANA CONTROL, MODEL 83-1004-01 |
PHADIA US INC. |
| K062583 |
09/01/2006 |
ELIA CELIKEY IGG WELL, MODEL 14-5518-01, ELIA CELIAC CONTROL, MODEL 83-1011-01 |
PHADIA US INC. |
| K062787 |
09/18/2006 |
ELIA CELIKEY IGA WELL, MODEL 14-5517-01; ELIA CELIAC CONTROL, MODEL 83-1011-01 |
PHADIA US INC. |
| K072661 |
09/21/2007 |
IMMUNOCAP THYRLOBULIN IMMUNOCAP |
PHADIA US INC. |
| K082759 |
09/22/2008 |
ELIA CENP IMMUNOASSAY, ELIA U1RNP IMMUNOASSAY, ELIA SM IMMUNOASSAY, ELIA RO IMMUNOASSAY |
PHADIA US INC. |
| K052793 |
10/03/2005 |
IMMUNOCAP/UNICAP GLIADIN IGA, IMMUNOCAP/UNICAP SPECIFIC IGA, MODELS 14-4425-40, 10-9306-02 |
PHARMACIA DIAGNOSTICS AB |
| K083188 |
10/29/2008 |
VARELISA RECOMBI ANA SCREEN, MODEL 12 596 |
PHADIA US INC. |
| K133404 |
11/06/2013 |
IMMUNOCAP TOTAL IGE: CONJUGATE, ANTI-IGE, CALIBRATORS, CURVE CONTROLS, CONTROL LMH |
PHADIA AB |
| K063775 |
12/21/2006 |
ELIA GLIADIN IGA, IGG AND CELIAC CONTROL |
PHADIA US INC. |
| K091845 |
06/22/2009 |
CARDIOLIPIN AUTOANTIBODY IMMUNOLOGICAL TEST SYSTEM |
PHADIA US INC. |
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