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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 K923445
Device Name PYLORAGEN HELICBACTER PYLORI TEST KIT - MODIFIED
Applicant
Hycor Biomedical, Inc.
7572 Chapman Ave.
Garden Grove,  CA  92641
Applicant Contact RONALD HOOVER
Correspondent
Hycor Biomedical, Inc.
7572 Chapman Ave.
Garden Grove,  CA  92641
Correspondent Contact RONALD HOOVER
Regulation Number866.3110
Classification Product Code
LYR  
Date Received07/08/1992
Decision Date 09/11/1992
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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