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510(k) K071277

SYNCHRON LX20 CLINICAL SYSTEMS, CREATININE TEST SYSTEMS by Beckman Coulter, Inc. — Product Code CGX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 1, 2007
Date Received
May 7, 2007
Clearance Type
Special
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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