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510(k) K834328

DAT TEST FOR CHAGAS' DISEASE by Sero-Immuno Diagnostics, Inc. — Product Code GNE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 2, 1984
Date Received
December 9, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antigen, Latex Agglutination, T. Cruzi
Device Class
Class I
Regulation Number
866.3870
Review Panel
MI
Submission Type

Other clearances by Sero-Immuno Diagnostics, Inc.

  • K852286 — DIRRECT AGGLUTINATION(DAG) PREGNANCY TEST (July 9, 1985)
  • K842181 — BETA-HCG HEMAGGLUTINATION TEST (August 22, 1984)