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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Thyroid-Stimulating Hormone
510(k) Number K872897
Device Name TSH SEROZYME IMMUNOENZYMETRIC KIT, MAG. SOLID PHA.
Applicant
Serono Diagnostics, Inc.
100 Longwater Cir.
Norwell,  MA  02061
Applicant Contact PHILIP M FANTASIA
Correspondent
Serono Diagnostics, Inc.
100 Longwater Cir.
Norwell,  MA  02061
Correspondent Contact PHILIP M FANTASIA
Regulation Number862.1690
Classification Product Code
JLW  
Date Received07/23/1987
Decision Date 07/31/1987
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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