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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Multi-Analyte Controls, All Kinds (Assayed)
510(k) Number K882727
Device Name AMERLITE TOTAL THYROID CONTROL SERA LAN.4001
Applicant
Amersham Corp.
2636 S. Clearbrook Dr.
Arlington Heights,  IL  60005
Applicant Contact FRANK J LYMAN
Correspondent
Amersham Corp.
2636 S. Clearbrook Dr.
Arlington Heights,  IL  60005
Correspondent Contact FRANK J LYMAN
Regulation Number862.1660
Classification Product Code
JJY  
Date Received07/01/1988
Decision Date 08/08/1988
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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