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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calibrator, Secondary
510(k) Number K792290
Device Name TSH STANDARDS & DILUENT
Applicant
Amersham Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Amersham Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number862.1150
Classification Product Code
JIT  
Date Received11/13/1979
Decision Date 12/06/1979
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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