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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 K890708
Device Name AMERLITE REPRODUCTIVE ENDOCRINOLOGY (LABEL CHANGE)
Applicant
AMERSHAM CORP.
2636 SOUTH CLEARBROOK DR.
ARLINGTON HEIGHTS,  IL  60005
Applicant Contact FRANK J LYMAN
Correspondent
AMERSHAM CORP.
2636 SOUTH CLEARBROOK DR.
ARLINGTON HEIGHTS,  IL  60005
Correspondent Contact FRANK J LYMAN
Regulation Number862.1660
Classification Product Code
JJY  
Date Received01/31/1989
Decision Date 03/20/1989
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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