BIOSCANNER CREATININE TEST STRIPS— 510(k) K010456

Substantially Equivalent

Polymer Technology Systems, Inc.

FDA 510(k) clearance K010456 for BIOSCANNER CREATININE TEST STRIPS, Substantially Equivalent on 2001-06-20. Applicant: Polymer Technology Systems, Inc..

Clearance details

Applicant: Polymer Technology Systems, Inc.
Product code: Code JFY
Advisory panel: Clinical Chemistry
Date received: 2001-02-16
Decision date: 2001-06-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

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