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510(k) K872568

ROTASCREEN by Mercia Diagnostics , Ltd. — Product Code GOB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 14, 1987
Date Received
June 29, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antigens, Ha (Including Ha Control), Adenovirus 1-33
Device Class
Class I
Regulation Number
866.3020
Review Panel
MI
Submission Type

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