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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 K851445
Device Name COLOR OVULATION TEST
Applicant
NMS PHARMACEUTICALS, INC.
1533 MONROVIA AVE.
NEWPORT BEACH,  CA  92663
Applicant Contact PERRY G RUCKER
Correspondent
NMS PHARMACEUTICALS, INC.
1533 MONROVIA AVE.
NEWPORT BEACH,  CA  92663
Correspondent Contact PERRY G RUCKER
Regulation Number862.1485
Classification Product Code
CEP  
Date Received04/11/1985
Decision Date 07/29/1985
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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