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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name radioimmunoassay, free thyroxine
510(k) Number K030329
Device Name FASTPACK FREE T4 IMMUNOASSAY
Applicant
Qualigen, Inc.
2042 CORTE DEL NOGAL
CARLSBAD,  CA  92009 -1410
Applicant Contact DOROTHY DEINZER
Correspondent
Qualigen, Inc.
2042 CORTE DEL NOGAL
CARLSBAD,  CA  92009 -1410
Correspondent Contact DOROTHY DEINZER
Regulation Number862.1695
Classification Product Code
CEC  
Subsequent Product Code
JIX  
Date Received01/31/2003
Decision Date 07/03/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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