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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 K953581
Device Name FIRST RESPONSE OVULATION PREDICTOR TEST
Applicant
ARMKEL, LLC.
HALF ACRE RD.
P.O. BOX 1001
CRANBURY,  NJ  08512
Applicant Contact Maureen Garner
Correspondent
ARMKEL, LLC.
HALF ACRE RD.
P.O. BOX 1001
CRANBURY,  NJ  08512
Correspondent Contact Maureen Garner
Regulation Number862.1485
Classification Product Code
CEP  
Date Received08/01/1995
Decision Date 10/03/1995
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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