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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 K920827
Device Name AMRAD HEL-PTEST
Applicant
Amrad
Washington Sq., Suite 1100
1050 Connecticut Ave., NW
Washington,  DC  20036
Applicant Contact BRUCE MACKLER
Correspondent
Amrad
Washington Sq., Suite 1100
1050 Connecticut Ave., NW
Washington,  DC  20036
Correspondent Contact BRUCE MACKLER
Regulation Number866.3110
Classification Product Code
LYR  
Date Received02/24/1992
Decision Date 07/14/1992
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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