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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers
510(k) Number K965085
Device Name ENZYMUN-TEST PSA
Applicant
Boehringer Mannheim Corp.
9115 Hague Rd.
Indianapolis,  IN  46250
Applicant Contact LEEANN CHAMBERS, RAC
Correspondent
Boehringer Mannheim Corp.
9115 Hague Rd.
Indianapolis,  IN  46250
Correspondent Contact LEEANN CHAMBERS, RAC
Regulation Number866.6010
Classification Product Code
LTJ  
Date Received12/19/1996
Decision Date 03/19/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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