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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 K883641
Device Name SELECTIVE RAPID UREA
Applicant
Remel Co.
12076 Santa Fe Dr.
Lenexa,  KS  66215
Applicant Contact BRENDA HENRY
Correspondent
Remel Co.
12076 Santa Fe Dr.
Lenexa,  KS  66215
Correspondent Contact BRENDA HENRY
Regulation Number866.3110
Classification Product Code
LYR  
Date Received08/25/1988
Decision Date 05/04/1989
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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