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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers
510(k) Number K003094
Device Name FASTPACK PSA IMMUNOASSAY, FASTPACK ANALYZER
Applicant
Qualigen, Inc.
2042 Corte Del Nogal
Carlsbad,  CA  92009
Applicant Contact DOROTHY DEINZER
Correspondent
Qualigen, Inc.
2042 Corte Del Nogal
Carlsbad,  CA  92009
Correspondent Contact DOROTHY DEINZER
Regulation Number866.6010
Classification Product Code
LTJ  
Date Received10/03/2000
Decision Date 10/25/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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