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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 K883530
Device Name FIRST RESPONSE 10 MINUTE OVULATION PREDICTOR TEST
Applicant
Tambrands, Inc.
Bridge & Springfield St.s
Palmer,  MA  01069
Applicant Contact BARBARA M DAVIS,PHD
Correspondent
Tambrands, Inc.
Bridge & Springfield St.s
Palmer,  MA  01069
Correspondent Contact BARBARA M DAVIS,PHD
Regulation Number862.1485
Classification Product Code
CEP  
Date Received08/18/1988
Decision Date 12/19/1988
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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