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510(k) K112414

ELIA B2-GLYCOPROTEIN I IGA IMMUNOASSAY by Phadia US, Inc. — Product Code MSV

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 22, 2012
Date Received
August 22, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi)
Device Class
Class II
Regulation Number
866.5660
Review Panel
IM
Submission Type

Other clearances by Phadia US, Inc.

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  • K132631 — EIA SMDP IMMUNOASSAY (August 29, 2014)
  • K131821 — ELIA(TM) CARDIOLIPIN IGA IMMUNOASSAY (December 23, 2013)
  • K122197 — AUTOMATED IN VITRO QUANTITATIVE ASSAY FOR THE MEASUREMENT OF ALLERGEN SPECIFIC I (August 28, 2013)
  • K113841 — IMMUNOCAP ALLERGEN COMPONENTS BUNDLE (September 13, 2012)
  • DEN120001 — IMMUNOCAP TRYPTASE, CALIBRATORS, CURVE CONTROL, CONJUGATE 50, CALIBRATOR STRIP, (February 15, 2012)
  • K111919 — IMMUNOCAP SPECIFIC IGE ALLERGEN BUNDLE, 12 ALLERGEN COMPONENTS (December 22, 2011)
  • K102673 — RHEUMATOID FACTOR IMMUNOLOGICAL TEST SYSTEM (September 30, 2011)
  • K093459 — ELIA GLIADIN DP IGA IMMUNOASSAY AND ELIA GLIADIN DP IGG IMMUNOASSAY, MODELS 14-5 (August 13, 2010)

Other clearances for product code MSV

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  • K162788 — ImmuLisa Enhanced B2GP1 IgA Antibody ELISA, ImmuLisa Enhanced B2GP1 IgG Antibody (June 19, 2017)
  • K152875 — QUANTA Flash B2GP1-Domain1, QUANTA Flash B2GP1-Domain1 Controls, HemosIL AcuStar (December 21, 2015)
  • K141274 — QUANTA FLASH ¿2GP1-DOMAIN1; CONTROLS, HEMOSIL ACUSTAR ANTI-¿2GPI DOMAIN1; CONTRO (February 13, 2015)
  • K091556 — HEMOSIL ACUSTAR ANTI-B2 GLYCOPROTEIN-I; IGG, IGM, IGG CONTROLS, IGM CONTROLS (May 21, 2010)
  • K092757 — THERATEST EL-BETA2GPI (IGM-IGG-IGA), THERATEST EL--BETA2GPI SCR (October 9, 2009)
  • K072032 — IGG ANTI-ATHEROX TEST KIT (April 4, 2008)
  • K062217 — AESKULSKA BETA2-GLYCO-A (December 13, 2006)
  • K040450 — VARELISA B2 GLYCOPROTEIN I IGA ANTIBODIES, MODELS 18948 AND 18996 (May 11, 2004)