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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Progesterone
510(k) Number K845026
Device Name AMERLEX-M PROGESTERONE RADIOIMMUNOASSAY KIT CODE
Applicant
Amersham Corp.
2636 S. Clearbrook Dr.
Arlington Heights,  IL  60005
Applicant Contact PHILIP M FANTASIA
Correspondent
Amersham Corp.
2636 S. Clearbrook Dr.
Arlington Heights,  IL  60005
Correspondent Contact PHILIP M FANTASIA
Regulation Number862.1620
Classification Product Code
JLS  
Date Received12/27/1984
Decision Date 02/01/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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