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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calibrator, Secondary
510(k) Number K003096
Device Name FASTPACK CALIBRATORS
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 Number862.1150
Classification Product Code
JIT  
Date Received10/03/2000
Decision Date 11/30/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Immunology
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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