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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 K843367
Device Name ROTAVIRUS ENZYME IMMUNOASSAY
Applicant
Intl. Diagnostic Laboratories, Ltd.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Intl. Diagnostic Laboratories, Ltd.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number866.3405
Classification Product Code
LIQ  
Date Received08/28/1984
Decision Date 06/13/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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