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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Colorimeter, Photometer, Spectrophotometer For Clinical Use
510(k) Number K921180
Device Name COBAS CORE IMMUNOCHEMISTRY SYSTEM
Applicant
Roche Diagnostic Systems, Inc.
1080 Us Hwy. 202
Branchburg,  NJ  08876
Applicant Contact CAROL L KRIEGER
Correspondent
Roche Diagnostic Systems, Inc.
1080 Us Hwy. 202
Branchburg,  NJ  08876
Correspondent Contact CAROL L KRIEGER
Regulation Number862.2300
Classification Product Code
JJQ  
Date Received03/10/1992
Decision Date 07/28/1992
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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