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510(k) K061193

CREATININE by Abbott Laboratories, Inc. — Product Code CGX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 23, 2006
Date Received
April 28, 2006
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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