Cleared Dual Track

K141775 - SOFIA (R) STREP A+ FIA (FDA 510(k) Clearance)

K141775 · Quidel Corporation · Microbiology device
Dec 2014
Decision
168d
Days
Class 1
Risk

K141775 is an FDA 510(k) clearance for the SOFIA (R) STREP A+ FIA. This device is classified as a Antigens, All Groups, Streptococcus Spp. (Class I - General Controls, product code GTY).

Submitted by Quidel Corporation (San Diego, US). The FDA issued a Cleared decision on December 16, 2014, 168 days after receiving the submission on July 1, 2014.

This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3740.

Submission Details

510(k) Number K141775 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 2014
Decision Date December 16, 2014
Days to Decision 168 days
Submission Type Dual Track
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code GTY — Antigens, All Groups, Streptococcus Spp.
Device Class Class I - General Controls
CFR Regulation 21 CFR 866.3740