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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 K934863
Device Name FLEXSURE HP
Applicant
Smithkline Diagnostics, Inc.
225 Baypointe Pkwy.
San Jose,  CA  95134
Applicant Contact MICHAEL A DANIEL
Correspondent
Smithkline Diagnostics, Inc.
225 Baypointe Pkwy.
San Jose,  CA  95134
Correspondent Contact MICHAEL A DANIEL
Regulation Number866.3110
Classification Product Code
LYR  
Date Received10/12/1993
Decision Date 05/18/1994
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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