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510(k) K020757

VARELISA CARDIOLIPIN IGA ANTIBODIES, MODELS 15748 & 15796 by Pharmacia Deutschland GmbH — Product Code MID

K020757 is an FDA 510(k) premarket notification submitted by Pharmacia Deutschland GmbH for the device "VARELISA CARDIOLIPIN IGA ANTIBODIES, MODELS 15748 & 15796". The FDA issued a decision of Substantially Equivalent on May 2, 2002. The device falls under product code MID (System, Test, Anticardiolipin Immunological), a Class II device regulated under 21 CFR 866.5660. Pharmacia Deutschland GmbH has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 2, 2002
Date Received
March 7, 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 Pharmacia Deutschland GmbH

  • K041043 — VARELISA PR3 ANCA, MODEL NUMBER 17748/17796 (July 2, 2004)
  • K040810 — VARELISA HISTONE ANTIBODIES, MODEL 16496 (May 14, 2004)
  • K040811 — VARELISA SSDNA ANTIBODIES, MODEL 14896 (May 13, 2004)
  • K040449 — VARELISA B2 GLYCOPROTEIN I IGG ANTIBODIES, MODELS 18748 AND 18796 (May 11, 2004)
  • K040451 — VARELISA B2 GLYCOPROTEIN I IGM ANTIBODIES, MODELS 18848 AND 18896 (May 11, 2004)
  • K040450 — VARELISA B2 GLYCOPROTEIN I IGA ANTIBODIES, MODELS 18948 AND 18996 (May 11, 2004)
  • K040452 — VARELISA B2 GLYCOPROTEIN I ANTIBODIES SCREEN, MODELS 19048 AND 19096 (May 11, 2004)
  • K020752 — VARELISA CARDIOLIPIN IGG ANTIBODIES, MODELS 15548 & 15596 (May 2, 2002)
  • K020758 — VARELISA CARDIOLIPIN IGM ANTIBODIES, MODELS 15648 & 15696 (May 2, 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