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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name multi-analyte controls, all kinds (assayed)
510(k) Number K041227
Device Name MODIFICATION TO:ROCHE DIAGNOSTICS PRECINORM UNIVERSAL AND PRECIPATH UNIVERSAL CONTROL SERA
Applicant
ROCHE DIAGNOSTICS CORP.
9115 HAGUE RD.
PO BOX 50457
INDIANAPOLIS,  IN  46250 -0457
Applicant Contact THERESA M AMBROSE
Correspondent
ROCHE DIAGNOSTICS CORP.
9115 HAGUE RD.
PO BOX 50457
INDIANAPOLIS,  IN  46250 -0457
Correspondent Contact THERESA M AMBROSE
Regulation Number862.1660
Classification Product Code
JJY  
Date Received05/10/2004
Decision Date 05/27/2004
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
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