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510(k) K022851

PH AND AMINES EXTERNAL CONTROL SET by Quidel Corp. — Product Code JJY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 27, 2002
Date Received
August 27, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Multi-Analyte Controls, All Kinds (Assayed)
Device Class
Class I
Regulation Number
862.1660
Review Panel
CH
Submission Type

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  • K113777 — QUIDEL MOLECULAR INFLUENZA A+B (March 15, 2012)
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