Cleared Traditional

SOFIA(R) HCG FIA

K131166 · Quidel Corp. · Chemistry
Aug 2013
Decision
100d
Days
Class 2
Risk

About This 510(k) Submission

K131166 is an FDA 510(k) clearance for the SOFIA(R) HCG FIA, a Visual, Pregnancy Hcg, Prescription Use (Class II — Special Controls, product code JHI), submitted by Quidel Corp. (San Diego, US). The FDA issued a Cleared decision on August 2, 2013, 100 days after receiving the submission on April 24, 2013. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1155.

Submission Details

510(k) Number K131166 FDA.gov
FDA Decision Cleared SESE
Date Received April 24, 2013
Decision Date August 02, 2013
Days to Decision 100 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code JHI — Visual, Pregnancy Hcg, Prescription Use
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1155

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