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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Analyzer, Chemistry, Centrifugal, For Clinical Use
510(k) Number K843914
Device Name COBAS FLUORESCENCE POLARIZATION MODULE
Applicant
Roche Diagnostic Systems, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Applicant Contact GRIFFIN FITZGERALD
Correspondent
Roche Diagnostic Systems, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent Contact GRIFFIN FITZGERALD
Regulation Number862.2140
Classification Product Code
JJG  
Date Received10/04/1984
Decision Date 11/27/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Toxicology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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