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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calibrator, Multi-Analyte Mixture
510(k) Number K962269
Device Name CEDIA CARDIAC TDM MULTI-CALS
Applicant
Boehringer Mannheim Corp.
2400 Bisso Ln.
P.O. Box 4117
Concord,  CA  94524
Applicant Contact MARY KONING
Correspondent
Boehringer Mannheim Corp.
2400 Bisso Ln.
P.O. Box 4117
Concord,  CA  94524
Correspondent Contact MARY KONING
Regulation Number862.1150
Classification Product Code
JIX  
Date Received06/13/1996
Decision Date 10/29/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Toxicology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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