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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enzyme Immunoassay, Amphetamine
510(k) Number K061718
FOIA Releasable 510(k) K061718
Device Name INNOVACON SPECTRUM II TEST CARD
Applicant
INNOVACON, INC.
4106 SORRENTO VALLEY BLVD.
SAN DIEGO,  CA  92121
Applicant Contact EDWARD TUNG
Correspondent
INNOVACON, INC.
4106 SORRENTO VALLEY BLVD.
SAN DIEGO,  CA  92121
Correspondent Contact EDWARD TUNG
Regulation Number862.3100
Classification Product Code
DKZ  
Subsequent Product Codes
DIO   DIS   DJC   DJG   DJR  
JXM   JXN   LCM   LDJ   LFG  
Date Received06/19/2006
Decision Date 11/13/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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