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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 K951796
Device Name CIBA CORNING ACS THYROID STIMULATING HORMONE (TSH-3) IMMUNOASSAY
Applicant
Ciba Corning Diagnostics Corp.
17392 Daimler St.
Irvine,  CA  92714
Applicant Contact STEVEN R RAKITIN
Correspondent
Ciba Corning Diagnostics Corp.
17392 Daimler St.
Irvine,  CA  92714
Correspondent Contact STEVEN R RAKITIN
Regulation Number862.1690
Classification Product Code
JLW  
Date Received04/19/1995
Decision Date 06/13/1995
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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