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510(k) K883915

AUTOANTIBODY TEST SYSTEM (MOUSE KIDNEY/STOMACH) by Immco Diagnostics, Inc. — Product Code DBL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 19, 1988
Date Received
September 16, 1988
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

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  • K113020 — IMMULISA ENHANCED (TM) CARDIOLIPIN IGA, IGG, IGM AND IGA/IGG/IGM ANTIBODY (ACA) (October 25, 2012)

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  • 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)