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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name nad reduction/nadh oxidation, cpk or isoenzymes
510(k) Number K051648
Device Name SPOTCHEM II INOGANIC PHOSPHORUS, CPK AND URIC ACID 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 Number862.1215
Classification Product Code
CGS  
Subsequent Product Codes
CEO   KNK  
Date Received06/21/2005
Decision Date 01/31/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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