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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enzyme Linked Immunoabsorbent Assay, Rotavirus
510(k) Number K912666
Device Name DAKO ELISA ROTAVIRUS KIT- 96 TESTS K440
Applicant
Dako Corp.
P.O. Box 1359
Dk-2600 Glostrup
Denmark,  DK
Applicant Contact DEBORA D HINMAN
Correspondent
Dako Corp.
P.O. Box 1359
Dk-2600 Glostrup
Denmark,  DK
Correspondent Contact DEBORA D HINMAN
Regulation Number866.3405
Classification Product Code
LIQ  
Date Received06/18/1991
Decision Date 02/14/1992
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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