CardioChek Plus Test System, CardioChek Home Test System, CardioChek PA Test System, CardioChek PA Home Test System— 510(k) K151545
Substantially EquivalentPolymer Technology Systems, Inc.
FDA 510(k) clearance K151545 for CardioChek Plus Test System, CardioChek Home Test System, CardioChek PA Test System, CardioChek PA Home Test System, Substantially Equivalent on 2016-12-22. Applicant: Polymer Technology Systems, Inc..
Clearance details
- Applicant
- Polymer Technology Systems, Inc.
- Product code
- Code CHH
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Indianapolis, IN, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.