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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 K851104
Device Name AMERLEX-M LUTEINIZING HORMONE RADIOIMMUNO-KIT
Applicant
AMERSHAM CORP.
2636 SOUTH CLEARBROOK DR.
ARLINGTON HEIGHTS,  IL  60005
Applicant Contact PHILIP M FRANTASIA
Correspondent
AMERSHAM CORP.
2636 SOUTH CLEARBROOK DR.
ARLINGTON HEIGHTS,  IL  60005
Correspondent Contact PHILIP M FRANTASIA
Regulation Number862.1485
Classification Product Code
CEP  
Date Received03/19/1985
Decision Date 04/10/1985
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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