SMART-READ EZTEST-STEAM SCBI AND TEST PACK— 510(k) K093794

Substantially Equivalent

Sgm Biotech, Inc.

FDA 510(k) clearance K093794 for SMART-READ EZTEST-STEAM SCBI AND TEST PACK, Substantially Equivalent on 2010-05-14. Applicant: Sgm Biotech, Inc..

Clearance details

Applicant: Sgm Biotech, Inc.
Product code: Code FRC
Advisory panel: General Hospital
Date received: 2009-12-10
Decision date: 2010-05-14
Decision: Substantially Equivalent
Clearance type: Special
Location: Bozeman, MT, US

Download summary PDF View on FDA.gov ↗

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