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510(k) K040008

QUICKVUE ADVANCE PH AND AMINES GLL TEST by Quidel Corp. — Product Code CEN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 29, 2004
Date Received
January 2, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dye-Indicator, Ph (Urinary, Non-Quantitative)
Device Class
Class I
Regulation Number
862.1550
Review Panel
CH
Submission Type

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