510(k) K123793

Device: SOFIA STREP A FIA
Applicant: QUIDEL CORPORATION
510(k) number: K123793
Product code: GTY
Decision: Substantially Equivalent (SESE)
Decision date: 2013-06-17
Date received: 2012-12-10
Regulation: 866.3740
Classification name: Antigens, All Groups, Streptococcus Spp.
Medical specialty: Microbiology
Review panel: Microbiology
Device class: 1
Clearance type: Traditional
Statement or summary: Summary
Third party reviewed: No

Applicant Contact#

Contact: JOHN D TAMERIUS, PH.D.
Address: 10165 Mckellar Ct. San Diego CA US 92121 92121

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Legacy Summary#

summary

FDA Review#

Decision Summary