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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Helicobacter Pylori
510(k) Number K953632
Device Name SERIM PYLORITEK TEST KIT
Applicant
Serim Research Corp.
1000 Randolph St., Bldg. 17
P.O. Box 4002
Elkhart,  IN  46514
Applicant Contact ROBERT J CARRICO
Correspondent
Serim Research Corp.
1000 Randolph St., Bldg. 17
P.O. Box 4002
Elkhart,  IN  46514
Correspondent Contact ROBERT J CARRICO
Regulation Number866.3110
Classification Product Code
LYR  
Date Received07/20/1995
Decision Date 12/18/1995
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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