STERITEC BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR— 510(k) K133549

Substantially Equivalent

Steritec Products Mfg Co, Inc.

FDA 510(k) clearance K133549 for STERITEC BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR, Substantially Equivalent on 2014-08-27. Applicant: Steritec Products Mfg Co, Inc..

Clearance details

Applicant: Steritec Products Mfg Co, Inc.
Product code: 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.