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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Estradiol
510(k) Number K912318
Device Name ESTRADIOL SEROZYME ENZYME IMMUNO (MAG SOLID-PHASE)
Applicant
Serono-Baker Diagnostics, Inc.
100 Cascade Dr.
Allentown,  PA  18103
Applicant Contact DAVID B THOMAS
Correspondent
Serono-Baker Diagnostics, Inc.
100 Cascade Dr.
Allentown,  PA  18103
Correspondent Contact DAVID B THOMAS
Regulation Number862.1260
Classification Product Code
CHP  
Date Received05/24/1991
Decision Date 07/25/1991
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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