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510(k) K880665

MODIFIED GROUP A STREPTOCOCCUS DETECTION KIT by Allelix Diagnostics, Inc. — Product Code GTZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 1, 1988
Date Received
February 18, 1988
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

Other clearances by Allelix Diagnostics, Inc.

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