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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 K925190
Device Name PYLORISCREEN
Applicant
New Horizons Diagnostics Co.
9110 Red Branch Rd.
Suite B
Columbia,  MD  21045
Applicant Contact MARJORIE L WIER
Correspondent
New Horizons Diagnostics Co.
9110 Red Branch Rd.
Suite B
Columbia,  MD  21045
Correspondent Contact MARJORIE L WIER
Regulation Number866.3110
Classification Product Code
LYR  
Date Received10/14/1992
Decision Date 03/23/1993
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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