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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 K880934
Device Name MODIFIED AMERLEX-M PROGESTERONE RADIOIMMUNO. KIT
Applicant
Amersham Corp.
2636 S. Clearbrook Dr.
Arlington Heights,  IL  60005
Applicant Contact FRANK J LYMAN
Correspondent
Amersham Corp.
2636 S. Clearbrook Dr.
Arlington Heights,  IL  60005
Correspondent Contact FRANK J LYMAN
Regulation Number862.1620
Classification Product Code
JLS  
Date Received03/07/1988
Decision Date 04/18/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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