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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name radioimmunoassay, free thyroxine
510(k) Number K883123
Device Name AMERLIITE FT4 ASSAY LAN.0006/2006 240/144 TEST KIT
Applicant
AMERSHAM CORP.
2636 SOUTH CLEARBROOK DR.
ARLINGTON HEIGHTS,  IL  60005
Applicant Contact FRANK LYMAN
Correspondent
AMERSHAM CORP.
2636 SOUTH CLEARBROOK DR.
ARLINGTON HEIGHTS,  IL  60005
Correspondent Contact FRANK LYMAN
Regulation Number862.1695
Classification Product Code
CEC  
Date Received07/26/1988
Decision Date 12/22/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
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