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510(k) K961765

MPO ELISA TEST SYSTEM by Immunoprobe, Inc. — Product Code MOB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 19, 1996
Date Received
May 7, 1996
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 Immunoprobe, Inc.

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  • K961764 — PR-3 ELISA TEST SYSTEM (August 19, 1996)
  • K951549 — EBNA IGG EIA TEST SYSTEM (April 29, 1996)
  • K952521 — CARDIOLIPIN IGM EIA TEST SYSTEM (February 9, 1996)
  • K952523 — CARDIOLIPIN IGG EIA TEST KIT (February 9, 1996)
  • K952522 — CARDIOLIPIN IGA EIA TEST SYSTEM (February 9, 1996)
  • K951362 — THYROGLOBULIN EIA TEST KIT (November 20, 1995)
  • K951364 — MICROSOMAL EIA TEST KIT (November 20, 1995)
  • K951363 — CARDIOLIPIN IGG,M,A EIA TEST SYSTEM (October 13, 1995)

Other clearances for product code MOB

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  • 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)