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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 K965099
Device Name ACCUMETER H. PYLORI TEST
Applicant
Chemtrak, Inc.
929 E. Arques Ave.
Sunnyvale,  CA  94086 -4520
Applicant Contact RODGER J RICHEAL
Correspondent
Chemtrak, Inc.
929 E. Arques Ave.
Sunnyvale,  CA  94086 -4520
Correspondent Contact RODGER J RICHEAL
Regulation Number866.3110
Classification Product Code
LYR  
Date Received12/20/1996
Decision Date 02/20/1997
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
Recalls CDRH Recalls
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