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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name enzymatic method, creatinine
510(k) Number K003261
Device Name CREATININE PLUS
Applicant
ROCHE DIAGNOSTICS CORP.
9115 HAGUE RD.
P.O. BOX 50457
INDIANAPOLIS,  IN  46250 -0457
Applicant Contact PRISCILLA A HAMILL
Correspondent
ROCHE DIAGNOSTICS CORP.
9115 HAGUE RD.
P.O. BOX 50457
INDIANAPOLIS,  IN  46250 -0457
Correspondent Contact PRISCILLA A HAMILL
Regulation Number862.1225
Classification Product Code
JFY  
Date Received10/18/2000
Decision Date 11/16/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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