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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 K870584
Device Name O.P.T.(TM) OVULATION PREDICTION TEST
Applicant
Warner-Lambert Co.
201 Tabor Rd.
Morris Plains,  NJ  07950
Applicant Contact CLARK, PHD
Correspondent
Warner-Lambert Co.
201 Tabor Rd.
Morris Plains,  NJ  07950
Correspondent Contact CLARK, PHD
Regulation Number862.1485
Classification Product Code
CEP  
Date Received02/11/1987
Decision Date 11/25/1987
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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