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510(k) K820069

WELLCOGEN GROUP B by Burroughs Wellcome Co. — Product Code GTZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 18, 1982
Date Received
January 12, 1982
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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