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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Discs, Strips And Reagents, Microorganism Differentiation
510(k) Number K936034
Device Name SERIM PYLORITEK REAGENT STRIPS
Applicant
Serim Research Corp.
P.O. Box 4002
Elkhart,  IN  46514
Applicant Contact J. MICHAEL MCKENNA
Correspondent
Serim Research Corp.
P.O. Box 4002
Elkhart,  IN  46514
Correspondent Contact J. MICHAEL MCKENNA
Regulation Number866.2660
Classification Product Code
JTO  
Date Received12/15/1993
Decision Date 04/21/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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