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510(k) K792429

HIM TEST COCAINE by Tecknam, Inc. — Product Code DLN

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: December 7, 1979
Date Received: November 28, 1979
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Hemagglutination, Cocaine Metabolites (Benzoylecgnonine)
Device Class: Class II
Regulation Number: 862.3250
Review Panel: TX
Submission Type