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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tetrazolium Int Dye-Diaphorase, Lactate Dehydrogenase
510(k) Number K050790
Device Name SPOTCHEM II LDH TEST
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 Number862.1440
Classification Product Code
CFH  
Date Received03/28/2005
Decision Date 06/06/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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