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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Test, Luteinizing Hormone (Lh), Over The Counter
510(k) Number K850579
Device Name CUE FERTILITY MONITOR
Applicant
Zetek, Inc.
Burditt, Bowles & Radzius, Ltd
135 S. La Salle St.
Chicago,  IL  60603
Applicant Contact Joseph R RADZIUS
Correspondent
Zetek, Inc.
Burditt, Bowles & Radzius, Ltd
135 S. La Salle St.
Chicago,  IL  60603
Correspondent Contact Joseph R RADZIUS
Regulation Number862.1485
Classification Product Code
NGE  
Date Received02/13/1985
Decision Date 03/22/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Toxicology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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