510(k) K013379

Device: SAS STREPALERT
Applicant: Sa Scientific, Inc.
510(k) number: K013379
Product code: GTY
Decision: Substantially Equivalent (SESE)
Decision date: 2001-12-12
Date received: 2001-10-12
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: Statement
Third party reviewed: N

Applicant Contact#

Contact: RICARDO R MARTINEZ
Address: 4919 Golden Quail San Antonio TX US 78240 78240

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA