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510(k) K791454

AGGLUTINOTEST-PERTUSSIS by Volu Sol Medical Industries — Product Code GOX

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
Antigen, B. Pertussis
Device Class
Class I
Regulation Number
866.3065
Review Panel
MI
Submission Type

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