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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 K912391
Device Name RUBALEX, MODIFICATION
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 Received05/24/1991
Decision Date 05/04/1992
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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