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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 K920576
Device Name AMERLEX-M HIGH SENSITIVITY UNCONJUGATED ESTRIOL
Applicant
Eastman Kodak Company
343 State St.
Rochester,  NY  14650
Applicant Contact YVONNE ADAIR
Correspondent
Eastman Kodak Company
343 State St.
Rochester,  NY  14650
Correspondent Contact YVONNE ADAIR
Regulation Number862.1265
Classification Product Code
CGI  
Date Received02/10/1992
Decision Date 03/23/1992
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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