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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 K901637
Device Name RESUBMITTED MODIFIED 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 Received04/09/1990
Decision Date 04/26/1990
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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