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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Visual, Pregnancy Hcg, Prescription Use
510(k) Number K072264
Device Name FASTPACK HCG IMMUNOASSAY
Applicant
Qualigen, Inc.
2042 Corte Del Nogal
Carlsbad,  CA  92011
Applicant Contact MICHAEL S POIRIER
Correspondent
Qualigen, Inc.
2042 Corte Del Nogal
Carlsbad,  CA  92011
Correspondent Contact MICHAEL S POIRIER
Regulation Number862.1155
Classification Product Code
JHI  
Subsequent Product Code
JIT  
Date Received08/15/2007
Decision Date 12/06/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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