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510(k) K062217

AESKULSKA BETA2-GLYCO-A by Aesku, Inc. — Product Code MSV

K062217 is an FDA 510(k) premarket notification submitted by Aesku, Inc. for the device "AESKULSKA BETA2-GLYCO-A". The FDA issued a decision of Substantially Equivalent on December 13, 2006. The device falls under product code MSV (System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi)), a Class II device regulated under 21 CFR 866.5660. Aesku, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 13, 2006
Date Received
August 1, 2006
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 Aesku, Inc.

  • K051492 — AESKULISA ASCA A (November 14, 2005)
  • K042644 — AESKULISA TTG A AND AESKULISA TTG G (June 1, 2005)
  • K040953 — AESKULISA ANA HEP-2 (June 23, 2004)
  • K040463 — AESKULISA CARDIOLIPIN AGM (May 12, 2004)
  • K032469 — AESKULISA ANA 8PRO (December 16, 2003)

Other clearances for product code MSV

  • K243979 — Aptiva APS IgA Reagent (February 6, 2026)
  • K181329 — EliA B2-Glycoprotein I IgA Immunoassay, EliA Cardiolipin IgA Immunoassay (June 25, 2018)
  • 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)
  • K112414 — ELIA B2-GLYCOPROTEIN I IGA IMMUNOASSAY (June 22, 2012)
  • 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)
  • K040449 — VARELISA B2 GLYCOPROTEIN I IGG ANTIBODIES, MODELS 18748 AND 18796 (May 11, 2004)

FDA data resources