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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 K002867
Device Name INVERNESS MEDICAL OVULATION PREDICTOR TEST
Applicant
SELFCARE, INC.
200 PROSPECT ST.
WALTHAM,  MA  02154 -3457
Applicant Contact CAROL A ADILETTO
Correspondent
SELFCARE, INC.
200 PROSPECT ST.
WALTHAM,  MA  02154 -3457
Correspondent Contact CAROL A ADILETTO
Regulation Number862.1485
Classification Product Code
CEP  
Date Received09/13/2000
Decision Date 10/12/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Special
Reviewed by Third Party No
Combination Product No
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