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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name radioimmunoassay, luteinizing hormone
510(k) Number K820753
Device Name AMERLEX LH RIA KIT (CODE IM2081)
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 Number862.1485
Classification Product Code
CEP  
Date Received03/19/1982
Decision Date 04/09/1982
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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