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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name bromcresol green dye-binding, albumin
510(k) Number K033009
Device Name ROCHE DIAGNOSTICS COBAS INTEGRA ALBUMIN GEN. 2
Applicant
ROCHE DIAGNOSTICS CORP.
9115 HAGUE RD.
INDIANAPOLIS,  IN  46250
Applicant Contact SHERRI L COENEN
Correspondent
ROCHE DIAGNOSTICS CORP.
9115 HAGUE RD.
INDIANAPOLIS,  IN  46250
Correspondent Contact SHERRI L COENEN
Regulation Number862.1035
Classification Product Code
CIX  
Date Received09/26/2003
Decision Date 10/16/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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