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510(k) K974169

WIELISA ANTI-GBM TEST SYSTEM by Wieslab AB — Product Code DBL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 17, 1998
Date Received
November 5, 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 Wieslab AB

  • K981748 — WIELISA ANCA SCREENING KIT TEST SYSTEM (July 22, 1998)
  • K981750 — WIELISA ANTI-GBM, ANCA SCREENING KIT TEST SYSTEM (July 22, 1998)
  • K974166 — WIELISA MPO ANCA TEST SYSTEM (February 17, 1998)
  • K974167 — WIELISA PR-3 ANCA TEST SYSTEM (February 17, 1998)

Other clearances for product code DBL

  • K180202 — Histofluor Rodent LKS Fluorescent Antibody Test System, Image Navigator by Immun (October 19, 2018)
  • K980312 — NOVA LITE ENDOMYSIAL (April 2, 1998)
  • K971464 — IMMUNOSCAN ANTI-GBM QUANTITATIVE KIT (October 29, 1997)
  • 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)