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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 K942974
Device Name PYLORISET DRY
Applicant
Orion Diagnostica, Div. Orion Corp.
Koivu-Mankkaan Tie 6
P.O. Box 83
02101 Espoo,  FI 02200
Applicant Contact TIMO RAINES
Correspondent
Orion Diagnostica, Div. Orion Corp.
Koivu-Mankkaan Tie 6
P.O. Box 83
02101 Espoo,  FI 02200
Correspondent Contact TIMO RAINES
Regulation Number866.3110
Classification Product Code
LYR  
Date Received06/20/1994
Decision Date 04/05/1995
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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