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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 K910837
Device Name SRI TSH IMMUNENZYMETRIC ASSAY
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 Number862.1690
Classification Product Code
JLW  
Date Received02/27/1991
Decision Date 05/24/1991
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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