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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 K991466
Device Name EARLY OVULATION PREDICTOR (CASSETTE), ONE STEP OVULATION PREDICTOR (CASSETTE), OVULATION PREDICTOR (CASSETTE)
Applicant
SELFCARE, INC.
200 PROSPECT ST.
WALTHAM,  MA  02154 -3457
Applicant Contact Carol Adiletto
Correspondent
SELFCARE, INC.
200 PROSPECT ST.
WALTHAM,  MA  02154 -3457
Correspondent Contact Carol Adiletto
Regulation Number862.1485
Classification Product Code
CEP  
Date Received04/27/1999
Decision Date 05/25/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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