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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 K871241
Device Name ANSWER OVULATION TEST KIT
Applicant
ARMKEL, LLC.
HALF ACRE RD.
P.O. BOX 1001
CRANBURY,  NJ  08512
Applicant Contact C KOLAKOWSKI
Correspondent
ARMKEL, LLC.
HALF ACRE RD.
P.O. BOX 1001
CRANBURY,  NJ  08512
Correspondent Contact C KOLAKOWSKI
Regulation Number862.1485
Classification Product Code
CEP  
Date Received03/27/1987
Decision Date 10/02/1987
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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