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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Immunoassay Method, Troponin Subunit
510(k) Number K974075
Device Name ACCESS TROPONIN I REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER
Applicant
Beckman Instruments, Inc.
1000 Lake Hazeltine Dr.
Chaska,  MN  55318 -1084
Applicant Contact JAN OLSEN
Correspondent
Beckman Instruments, Inc.
1000 Lake Hazeltine Dr.
Chaska,  MN  55318 -1084
Correspondent Contact JAN OLSEN
Regulation Number862.1215
Classification Product Code
MMI  
Date Received10/29/1997
Decision Date 11/10/1997
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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