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510(k) K020241

QACA IGG/IGM ELISA KIT by Cheshire Diagnostics , Ltd. — Product Code MID

K020241 is an FDA 510(k) premarket notification submitted by Cheshire Diagnostics , Ltd. for the device "QACA IGG/IGM ELISA KIT". The FDA issued a decision of Substantially Equivalent on March 13, 2002. The device falls under product code MID (System, Test, Anticardiolipin Immunological), 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
March 13, 2002
Date Received
January 23, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Test, Anticardiolipin Immunological
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)
  • K020695 — QAB2A IGG ELISA KIT (April 19, 2002)

Other clearances for product code MID

  • K223093 — Aptiva APS IgG Reagent; Aptiva APS IgM Reagent (December 17, 2024)
  • K131821 — ELIA(TM) CARDIOLIPIN IGA IMMUNOASSAY (December 23, 2013)
  • K130528 — BIOPLEX 2200 APLS IGM (October 21, 2013)
  • K120817 — QUANTA FLASH ACL LGA, QUANTA FLASH B2GP1 IGA (February 26, 2013)
  • K113020 — IMMULISA ENHANCED (TM) CARDIOLIPIN IGA, IGG, IGM AND IGA/IGG/IGM ANTIBODY (ACA) (October 25, 2012)
  • K103834 — BIOPLEX 2200 APLS IGG AND IGA KIT AND CALIBRATOR AND CONTROL SETS (March 30, 2012)
  • K102425 — ZEUS ELISA CARDIOLIPIN IGG/IGM/IGA TEST SYSTEM (December 12, 2011)
  • K091845 — CARDIOLIPIN AUTOANTIBODY IMMUNOLOGICAL TEST SYSTEM (June 7, 2010)
  • K092181 — HEMOSIL ACUSTAR CARDIOLIPIN IGG, IGM AND IGG AND IGM CONTROLS (March 11, 2010)
  • K060176 — EL-ACL SCREEN; EL-ACL IGM, IGG, IGA (February 7, 2006)

FDA data resources