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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 K860900
Device Name IMMPULSE FREE ESTRIOL ASSAY REAGENTS
Applicant
Sclavo, Inc.
1240 Elko Dr.
Sunnyvale,  CA  94089
Applicant Contact MICHAEL BRINKLEY
Correspondent
Sclavo, Inc.
1240 Elko Dr.
Sunnyvale,  CA  94089
Correspondent Contact MICHAEL BRINKLEY
Regulation Number862.1265
Classification Product Code
CGI  
Date Received03/10/1986
Decision Date 04/28/1986
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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