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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, Rubella
510(k) Number K883182
Device Name FIAGEN RUBELLA IGG
Applicant
Cyberfluor, Inc.
179 John St., 4th Floor ,
Toronto
Ontario M5t 1x4,  CA
Applicant Contact JAMES CLELLAND
Correspondent
Cyberfluor, Inc.
179 John St., 4th Floor ,
Toronto
Ontario M5t 1x4,  CA
Correspondent Contact JAMES CLELLAND
Regulation Number866.3510
Classification Product Code
LFX  
Date Received07/28/1988
Decision Date 10/31/1988
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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