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510(k) K791452

AGGLUTINOTEST-TUBERCULOSIS by Volu Sol Medical Industries — Product Code GRT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 24, 1979
Date Received
August 6, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antiserum, Fluorescent, Mycobacterium Tuberculosis
Device Class
Class I
Regulation Number
866.3370
Review Panel
MI
Submission Type

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