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510(k) K844399

RESPIRALEX LATEX AGGLUTINATION TEST by Orion Diagnostica, Inc. — Product Code GTZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 8, 1985
Date Received
November 13, 1984
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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