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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 K904655
Device Name PYLORISET
Applicant
Orion Diagnostica, Inc.
P.O. Box 83
02101 Espoo,  FI
Applicant Contact TIMO RAINES
Correspondent
Orion Diagnostica, Inc.
P.O. Box 83
02101 Espoo,  FI
Correspondent Contact TIMO RAINES
Regulation Number866.3110
Classification Product Code
LYR  
Date Received10/12/1990
Decision Date 10/21/1991
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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