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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name cresolphthalein complexone, calcium
510(k) Number K053401
Device Name SPOTCHEM II CHEMISTRY BASIC 1 AND CHEMISTRY BASIC 2 TESTS
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 Number862.1145
Classification Product Code
CIC  
Subsequent Product Codes
CEK   CGA   CGX   CIX   JGZ  
Date Received12/06/2005
Decision Date 03/24/2006
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
Recalls CDRH Recalls
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