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510(k) K040332

POLYMEDCO SPOTCHEM EZ CHEMISTRY ANALYZER by Arkray, Inc. — Product Code JJF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 16, 2004
Date Received
February 10, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Analyzer, Chemistry, Micro, For Clinical Use
Device Class
Class I
Regulation Number
862.2170
Review Panel
CH
Submission Type

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