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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate)
510(k) Number K942051
Device Name SR1 DHEA-S ENZYME IMMUNOASSAY
Applicant
Serono Diagnostics, Inc.
100 Cascade Dr.
Allentown,  PA  18103
Applicant Contact RICHARD D ECKLOFF
Correspondent
Serono Diagnostics, Inc.
100 Cascade Dr.
Allentown,  PA  18103
Correspondent Contact RICHARD D ECKLOFF
Regulation Number862.1245
Classification Product Code
JKC  
Date Received04/28/1994
Decision Date 07/13/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Toxicology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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