K133549

Substantially Equivalent

STERITEC BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR

Applicant: Steritec Products Mfg Co, Inc.
Product code: FRC
Advisory panel: General Hospital
Date received: 2013-11-19
Decision date: 2014-08-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Engelwood, CO, US

Download summary PDF View on FDA.gov ↗

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