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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Multi-Analyte Controls, All Kinds (Assayed)
510(k) Number K983492
Device Name BOEHRINGER MANNHEIM ELECSYS PRESICONTROL CARDIAC
Applicant
Boehringer Mannheim Corp.
9115 Hague Rd., P.O. Box 50457
Indianapolis,  IN  46250 -0457
Applicant Contact PRISCILLA A HAMILL
Correspondent
Boehringer Mannheim Corp.
9115 Hague Rd., P.O. Box 50457
Indianapolis,  IN  46250 -0457
Correspondent Contact PRISCILLA A HAMILL
Regulation Number862.1660
Classification Product Code
JJY  
Date Received10/05/1998
Decision Date 10/09/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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