Cleared Traditional

QUIDEL CH50 EQ EIA

K974111 · Quidel Corp. · Immunology
Jul 1998
Decision
271d
Days
Class 2
Risk

About This 510(k) Submission

K974111 is an FDA 510(k) clearance for the QUIDEL CH50 EQ EIA, a Complement C9, Antigen, Antiserum, Control (Class II — Special Controls, product code DAE), submitted by Quidel Corp. (San Diego, US). The FDA issued a Cleared decision on July 29, 1998, 271 days after receiving the submission on October 31, 1997. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5240.

Submission Details

510(k) Number K974111 FDA.gov
FDA Decision Cleared SESE
Date Received October 31, 1997
Decision Date July 29, 1998
Days to Decision 271 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

Product Code DAE — Complement C9, Antigen, Antiserum, Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5240

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