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510(k) K983740

IS-ANTI-PR3 IGG ELISA TEST SYSTEM by Columbia Bioscience, Inc. — Product Code MOB

K983740 is an FDA 510(k) premarket notification submitted by Columbia Bioscience, Inc. for the device "IS-ANTI-PR3 IGG ELISA TEST SYSTEM". The FDA issued a decision of Substantially Equivalent on November 18, 1998. The device falls under product code MOB (Test System, Antineutrophil Cytoplasmic Antibodies (Anca)), a Class II device regulated under 21 CFR 866.5660. Columbia Bioscience, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 18, 1998
Date Received
October 22, 1998
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 Columbia Bioscience, Inc.

  • K990462 — IS H. PYLORI IGG ELISA TEST SYSTEM (September 3, 1999)
  • K991274 — MUMPS IGG ELISA TEST SYSTEM (September 3, 1999)
  • K984228 — IS ANTI-TPO IGG ELISA TEST SYSTEM (February 2, 1999)
  • K983605 — IS BORRELIA BURGDORFERI IGG/IGM ELISA TEST SYSTEM (December 16, 1998)
  • K983606 — IS BORRELIA BURGDORFERI IGM TEST SYSTEM (December 16, 1998)
  • K983553 — ANTI-TG IGG ELISA TEST SYSTEM (December 7, 1998)
  • K982348 — EBNA-1 IGM ELISA TEST SYSTEM (November 25, 1998)
  • K982352 — VCA IGM ELISA TEST SYSTEM (November 25, 1998)
  • K982350 — EA-D IGM ELISA TEST SYSTEM (November 25, 1998)
  • K983390 — IS-ANTI-MPO IGG ELISA TEST SYSTEM (November 18, 1998)

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