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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dye-Indicator, Ph (Urinary, Non-Quantitative)
510(k) Number K040008
Device Name QUICKVUE ADVANCE PH AND AMINES GLL TEST
Applicant
Quidel Corp.
10165 Mckellar Ct.
San Diego,  CA  92121
Applicant Contact JENNIFER S HANKARD
Correspondent
Quidel Corp.
10165 Mckellar Ct.
San Diego,  CA  92121
Correspondent Contact JENNIFER S HANKARD
Regulation Number862.1550
Classification Product Code
CEN  
Date Received01/02/2004
Decision Date 04/29/2004
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
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