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510(k) K053401

SPOTCHEM II CHEMISTRY BASIC 1 AND CHEMISTRY BASIC 2 TESTS by Arkray, Inc. — Product Code CIC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 24, 2006
Date Received
December 6, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cresolphthalein Complexone, Calcium
Device Class
Class II
Regulation Number
862.1145
Review Panel
CH
Submission Type

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