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510(k) K003069

ANTI-CARDIOLIPIN, MULTIPLE AUTOANTIBODIES IMMUNOLOGICAL TEST SYSTEM by Quest Intl., Inc. — Product Code MID

K003069 is an FDA 510(k) premarket notification submitted by Quest Intl., Inc. for the device "ANTI-CARDIOLIPIN, MULTIPLE AUTOANTIBODIES IMMUNOLOGICAL TEST SYSTEM". The FDA issued a decision of Substantially Equivalent on November 27, 2000. The device falls under product code MID (System, Test, Anticardiolipin Immunological), a Class II device regulated under 21 CFR 866.5660. Quest Intl., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 27, 2000
Date Received
October 2, 2000
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 Quest Intl., Inc.

  • K091260 — SERAQUEST EBV EA-D IGG TEST (June 8, 2009)
  • K033915 — MODIFICATION TO SERAQUEST EB VCA IGG (January 16, 2004)
  • K033780 — MODIFICATION TO SERAQUEST VCA IGM (January 15, 2004)
  • K023593 — SERAQUEST ANTI-THYROID PEROXIDASE (TPO) (February 6, 2003)
  • K023592 — SERAQUEST ANTI-THYROGLOBULIN (January 6, 2003)
  • K991975 — SERAQUEST EB NA IGG (November 2, 1999)
  • K990410 — SERAQUEST EB VCA IGG (October 28, 1999)
  • K990977 — SERAQUEST EB VAC IGM (October 6, 1999)
  • K982485 — SERAQUEST CMV IGM (January 13, 1999)
  • K982281 — SERAQUEST RUBELLA IGM (October 16, 1998)

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