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510(k) K033058

CREATININE REAGENT KIT FOR BECKMAN SYNCHRON CX & CX DELTA SYSTEMS by Diamond Diagnostics, Inc. — Product Code CGX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 30, 2004
Date Received
September 29, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Alkaline Picrate, Colorimetry, Creatinine
Device Class
Class II
Regulation Number
862.1225
Review Panel
CH
Submission Type

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