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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Single (Specified) Analyte Controls (Assayed And Unassayed)
510(k) Number K062957
Device Name FASTPACK TOTAL PSA METHOD VERIFICATION KIT
Applicant
Qualigen, Inc.
2042 Corte Del Nogal
Carlsbad,  CA  92011
Applicant Contact MELISSA SAAM
Correspondent
Qualigen, Inc.
2042 Corte Del Nogal
Carlsbad,  CA  92011
Correspondent Contact MELISSA SAAM
Regulation Number862.1660
Classification Product Code
JJX  
Date Received09/29/2006
Decision Date 04/02/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Immunology
Summary Summary
FDA Review Decision Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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