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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calculator/Data Processing Module, For Clinical Use
510(k) Number K923316
Device Name EXPRESSO CARTRIDGE
Applicant
Bio-Rad Laboratories, Inc.
1000 Lake Hazeltine Dr.
Chaska,  MN  55318
Applicant Contact JOAN CHRISTENSON
Correspondent
Bio-Rad Laboratories, Inc.
1000 Lake Hazeltine Dr.
Chaska,  MN  55318
Correspondent Contact JOAN CHRISTENSON
Regulation Number862.2100
Classification Product Code
JQP  
Date Received07/07/1992
Decision Date 02/23/1993
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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