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510(k) K942093

REMEL RIM STREPTOCOCCUS GROUPING LATEX AGGLUTINATION TEST by Medical Diagnostic Technologies, Inc. — Product Code GTZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 28, 1994
Date Received
May 2, 1994
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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