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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name multi-analyte controls, all kinds (assayed)
510(k) Number K123725
Device Name FASTPACK CONTROL KIT
Applicant
Qualigen, Inc.
2042 CORTE DEL NOGAL
CARLSBAD,  CA  92011
Applicant Contact Michael Poirier
Correspondent
Qualigen, Inc.
2042 CORTE DEL NOGAL
CARLSBAD,  CA  92011
Correspondent Contact Michael Poirier
Regulation Number862.1660
Classification Product Code
JJY  
Date Received12/04/2012
Decision Date 03/08/2013
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
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