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510(k) K760098

REAGENT, VDRL by Gamma Biologicals, Inc. — Product Code GMT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 3, 1976
Date Received
June 14, 1976
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antigens, Ha, Treponema Pallidum
Device Class
Class II
Regulation Number
866.3830
Review Panel
MI
Submission Type

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  • K800658 — RST-SERIES CONTROL (April 16, 1980)

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