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510(k) K020695

QAB2A IGG ELISA KIT by Cheshire Diagnostics , Ltd. — Product Code MSV

K020695 is an FDA 510(k) premarket notification submitted by Cheshire Diagnostics , Ltd. for the device "QAB2A IGG ELISA KIT". The FDA issued a decision of Substantially Equivalent on April 19, 2002. 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. Cheshire Diagnostics , Ltd. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 19, 2002
Date Received
March 4, 2002
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 Cheshire Diagnostics , Ltd.

  • K021610 — QAB2A IGM ELISA KIT HRP (July 12, 2002)
  • K021611 — QAB2A IGG ELISA KIT HRP (July 12, 2002)
  • K021192 — QACA IGG/IGM ELISA KIT HRP (May 16, 2002)
  • K020694 — QAB2A IGM ELISA KIT (April 19, 2002)
  • K020241 — QACA IGG/IGM ELISA KIT (March 13, 2002)

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)
  • K062217 — AESKULSKA BETA2-GLYCO-A (December 13, 2006)

FDA data resources