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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Analyzer, Chemistry, Micro, For Clinical Use
510(k) Number K040332
Device Name POLYMEDCO SPOTCHEM EZ CHEMISTRY ANALYZER
Applicant
ARKRAY, INC.
510 FURNACE DOCK RD.
CORTLANDT MANOR,  NY  10567
Applicant Contact HELEN LANDICHO
Correspondent
ARKRAY, INC.
510 FURNACE DOCK RD.
CORTLANDT MANOR,  NY  10567
Correspondent Contact HELEN LANDICHO
Regulation Number862.2170
Classification Product Code
JJF  
Subsequent Product Codes
CGA   CKA  
Date Received02/10/2004
Decision Date 06/16/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Statement Statement
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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