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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 K912215
Device Name PYLORITRAK
Applicant
Bainbridge Laboratories, Inc.
7861 Day Rd. W.
Bainbridge Island,  WA  98110
Applicant Contact MAX LYON
Correspondent
Bainbridge Laboratories, Inc.
7861 Day Rd. W.
Bainbridge Island,  WA  98110
Correspondent Contact MAX LYON
Regulation Number866.3110
Classification Product Code
LYR  
Date Received05/20/1991
Decision Date 10/04/1991
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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