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510(k) K936034

SERIM PYLORITEK REAGENT STRIPS by Serim Research Corp. — Product Code JTO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 21, 1994
Date Received
December 15, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Discs, Strips And Reagents, Microorganism Differentiation
Device Class
Class I
Regulation Number
866.2660
Review Panel
MI
Submission Type

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