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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Estriol
510(k) Number K850787
Device Name SOLID PHASE FREE ESTRIOL ENZYME IMMUNOASSAY
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 Number862.1265
Classification Product Code
CGI  
Date Received02/26/1985
Decision Date 03/26/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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