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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Latex Agglutination Assay, Rubella
510(k) Number K852788
Device Name RUBALEX
Applicant
Orion Corp.
P.O. Box 425
20101 Turku,  FI
Applicant Contact TIMO RAINES
Correspondent
Orion Corp.
P.O. Box 425
20101 Turku,  FI
Correspondent Contact TIMO RAINES
Regulation Number866.3510
Classification Product Code
LQN  
Date Received07/01/1985
Decision Date 03/12/1986
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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