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510(k) K854929

OXOID STREPTOCOCAL GROUPING KIT by Oxoid U.S.A., Inc. — Product Code GTZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 11, 1986
Date Received
December 10, 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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