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510(k) K904181

ANTI-GBM ANTIBODIES QUANTITATIVE KIT by Biochemical Diagnostic, Inc. — Product Code DBL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 10, 1991
Date Received
September 11, 1990
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 Biochemical Diagnostic, Inc.

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  • K925586 — DETECTABUSE(TM) (December 28, 1992)
  • K841831 — CANNU-SKREEN-PRELIMINARY (July 6, 1984)

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  • 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)