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510(k) K853073

CULTURETTE BRAND 10-MINUTE GROUP A STREP I.D. by Marion Laboratories, Inc. — Product Code GTZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 1, 1985
Date Received
July 23, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antisera, All Groups, Streptococcus Spp.
Device Class
Class I
Regulation Number
866.3740
Review Panel
MI
Submission Type

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