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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 -9562
Applicant Contact david b thomas
Correspondent
SERONO-BAKER DIAGNOSTICS, INC.
100 CASCADE DR.
allentown,  PA  18103 -9562
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
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