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510(k) K974701

ORGENTEC ANTI-MPO (P-ANCA) ELISA by American Laboratory Products Co., Ltd. — Product Code MOB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 17, 1998
Date Received
December 8, 1997
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 American Laboratory Products Co., Ltd.

  • K012576 — CIC-C1Q EIA (January 29, 2002)
  • K011415 — ALPCO MILENIA ANTI-TG EIA (May 30, 2001)
  • K011201 — ALPCO MILENIA ANTI-TPO ELISA (May 24, 2001)
  • K974702 — ORGENTEC ANTI-PR3 (C-ANCA) ELISA (February 17, 1998)
  • K972190 — THYROGLOBULIN ASSAY SYSTEM (July 14, 1997)
  • K970932 — ORGENTEC MICRO-ALBUMIN EIA ASSAY (April 8, 1997)
  • K962057 — ORGENTEC ANTI-RNP/SM ELISA (November 18, 1996)
  • K962062 — ORGENTEC ANTI-SM ELISA (November 18, 1996)
  • K962052 — ORGENTEC ABTI-SS-BB(LA) ELISA (November 15, 1996)
  • K962055 — ORGENTEC ANTI-SCL 70 ELISA (November 15, 1996)

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)
  • K092600 — IMMULISA PR3 ANTIBODY ELISA (October 7, 2010)
  • K092601 — IMMULISA ANCA SCREEN ELISA (October 7, 2010)