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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Thyroid-Stimulating Hormone
510(k) Number K052301
Device Name FASTPACK TSH IMMUNOASSAY
Applicant
Qualigen, Inc.
2042 Corte Del Nogal
Carlsbad,  CA  92011
Applicant Contact DOROTHY PETERSON
Correspondent
Qualigen, Inc.
2042 Corte Del Nogal
Carlsbad,  CA  92011
Correspondent Contact DOROTHY PETERSON
Regulation Number862.1690
Classification Product Code
JLW  
Subsequent Product Codes
JIT   JJX  
Date Received08/22/2005
Decision Date 01/04/2006
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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