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510(k) K971464

IMMUNOSCAN ANTI-GBM QUANTITATIVE KIT by Euro-Diagnostica AB — Product Code DBL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 29, 1997
Date Received
April 22, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control
Device Class
Class II
Regulation Number
866.5660
Review Panel
IM
Submission Type

Other clearances by Euro-Diagnostica AB

  • K093908 — CCPOINT (December 1, 2010)
  • K091657 — IMMUNOSCAN CCPLUS (November 19, 2009)
  • K062045 — EDIA ANTI-CCP (December 4, 2006)
  • K971689 — IMMUNOSCAN ANTI-MYELOPEROXIDASE ANTIBODIES (MPO-ANCA) QUANTITATIVE KIT (October 29, 1997)
  • K971690 — IMMUNOSCAN PR3-ANCA (October 29, 1997)

Other clearances for product code DBL

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  • K980312 — NOVA LITE ENDOMYSIAL (April 2, 1998)
  • K974169 — WIELISA ANTI-GBM TEST SYSTEM (February 17, 1998)
  • K971658 — MOUSE LIVER KIDNEY STOMACH DIAGNOSTIC TEST KIT (May 23, 1997)
  • K963525 — DIASTAT ANTI-GLOMERULAR BASEMENT MEMBRANE KIT (November 7, 1996)
  • K955431 — RIT LIVER, KIDNEY, STOMACH IFA KIT (April 23, 1996)
  • K953495 — EIA KIT FOR THE DETECTION OF GBM ANTIBODIES (April 10, 1996)
  • K944191 — ANTI-NUCLEAR ANTIBODY(ANA) TEST KIT W/MOUSE LIVER (March 6, 1995)
  • K944192 — ANTI-NUCLEAR ANTIBODY (ANA) TEST KIT W/RAT LIVER (March 6, 1995)
  • K913360 — ANTI-RETICULIN ANTIBODY (ARA) TEST (September 26, 1994)