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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Luteinizing Hormone
510(k) Number K874624
Device Name FIAGEN(TM) HLH CATALOGUE NUMBER: 102-301
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 Number862.1485
Classification Product Code
CEP  
Date Received11/10/1987
Decision Date 01/11/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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