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510(k) K812603

TANARAMA by Marketing Consultants of America — Product Code GGG

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: November 20, 1981
Date Received: September 15, 1981
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Guaiac Reagent
Device Class: Class II
Regulation Number: 864.6550
Review Panel: HE
Submission Type