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510(k) K041043

VARELISA PR3 ANCA, MODEL NUMBER 17748/17796 by Pharmacia Deutschland GmbH — Product Code MOB

K041043 is an FDA 510(k) premarket notification submitted by Pharmacia Deutschland GmbH for the device "VARELISA PR3 ANCA, MODEL NUMBER 17748/17796". The FDA issued a decision of Substantially Equivalent on July 2, 2004. The device falls under product code MOB (Test System, Antineutrophil Cytoplasmic Antibodies (Anca)), 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
July 2, 2004
Date Received
April 22, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Test System, Antineutrophil Cytoplasmic Antibodies (Anca)
Device Class
Class II
Regulation Number
866.5660
Review Panel
IM
Submission Type

Other clearances by Pharmacia Deutschland GmbH

  • K040810 — VARELISA HISTONE ANTIBODIES, MODEL 16496 (May 14, 2004)
  • K040811 — VARELISA SSDNA ANTIBODIES, MODEL 14896 (May 13, 2004)
  • K040452 — VARELISA B2 GLYCOPROTEIN I ANTIBODIES SCREEN, MODELS 19048 AND 19096 (May 11, 2004)
  • K040451 — VARELISA B2 GLYCOPROTEIN I IGM ANTIBODIES, MODELS 18848 AND 18896 (May 11, 2004)
  • K040449 — VARELISA B2 GLYCOPROTEIN I IGG ANTIBODIES, MODELS 18748 AND 18796 (May 11, 2004)
  • K040450 — VARELISA B2 GLYCOPROTEIN I IGA ANTIBODIES, MODELS 18948 AND 18996 (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)
  • K020757 — VARELISA CARDIOLIPIN IGA ANTIBODIES, MODELS 15748 & 15796 (May 2, 2002)

Other clearances for product code MOB

  • K243776 — Anti-Neutrophil Cytoplasmic Antibodies (Ethanol-Fixed); Anti-Neutrophil Cytoplas (May 7, 2025)
  • K172582 — EUROIMMUN IFA Granulocyte Mosaic™ EUROPattern and EUROIMMUN EUROPLUS Granulocyte (May 24, 2018)
  • K172461 — AESKUSLIDES ANCA Ethanol, AESKUSLIDES ANCA Formalin (March 23, 2018)
  • K173792 — EliA PR3s Immunoassay; EliA MPOs Immunoassay; EliA GBM Immunoassay (March 13, 2018)
  • K161258 — NOVA Lite DAPI ANCA Ethanol Kit, NOVA Lite DAPI ANCA Formalin Kit (February 3, 2017)
  • K140225 — ELIA PR3S IMMUNOASSAY, ELIA MPOS IMMUNOASSAY, ELIA GBM IMMUNOASSAY, ELIA ANCA/GB (October 27, 2014)
  • K112545 — QUANTA FLASH PR3, QUANTA FLASH MPO, QUANTA FLASH GBM (July 31, 2012)
  • K100917 — FIDIS VASCULITIS ASSAY KIT AND ANALYZER AND CARIS SYSTEM (November 3, 2010)
  • K092601 — IMMULISA ANCA SCREEN ELISA (October 7, 2010)
  • K092599 — IMMULISA MPO ANTIBODY ELISA (October 7, 2010)

FDA data resources