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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Test, Immunoassay, Biosensor, Hcg
510(k) Number K012943
Device Name THE QUANTECH FASTRAQ AUTOMATED ANALYZER, AND THE QUANTECH PREPAQ TOTAL HCG TEST CARTRIDGE
Applicant
Quantech , Ltd.
9418 Lasaine Ave.
Northridge,  CA  91325
Applicant Contact ROBIN J HELLEN
Correspondent
Quantech , Ltd.
9418 Lasaine Ave.
Northridge,  CA  91325
Correspondent Contact ROBIN J HELLEN
Regulation Number862.1155
Classification Product Code
NAL  
Date Received08/31/2001
Decision Date 01/18/2002
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
Predetermined Change
Control Plan Authorized		 No
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