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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
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