SOFIA INFLUENZA A+B FIA— 510(k) K131606

Substantially Equivalent

Quidel Corp.

FDA 510(k) clearance K131606 for SOFIA INFLUENZA A+B FIA, Substantially Equivalent on 2013-07-05. Applicant: Quidel Corp.. Device class: 1.

Clearance details

Applicant: Quidel Corp.
Product code: Code GNX
Device class: Class 1
Regulation: 21 CFR 866.3330
Advisory panel: Microbiology
Date received: 2013-06-03
Decision date: 2013-07-05
Decision: Substantially Equivalent
Clearance type: Special
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GNX

K133411 — ALERE BINAXNOW INFLUENZA A & B CARD2013-12-05
K132352 — SAS FLUALERT A & B, SAS INFLUENZA A TEST2013-08-22
K131804 — REMEL XPECT FLU A&B2013-07-12
K131599 — QUICK VUE INFLUENZA2013-07-05
K131619 — QUICKVUE INFLUENZA A+B2013-06-28

More clearances from Quidel Corp.

K131813 — QUIDEL MOLECULAR RSV + HMPV ASSAY2013-09-06
K131728 — QUIDEL MOLECULAR INFLUENZA A + B ASSAY2013-08-29
K130398 — SOFIA(R) RSV FIA2013-08-13
K131166 — SOFIA(R) HCG FIA2013-08-02
K122189 — QUIDEL MOLECULAR RSV + HMPV ASSAY2013-03-08

Data sourced from openFDA. This site is unofficial and independent of the FDA.