CardioChek Plus Test System, CardioChek Home Test System— 510(k) K162282
Substantially EquivalentPolymer Technology Systems, Inc. D/B/A Pts Diagnostics
FDA 510(k) clearance K162282 for CardioChek Plus Test System, CardioChek Home Test System, Substantially Equivalent on 2016-12-22. Applicant: Polymer Technology Systems, Inc. D/B/A Pts Diagnostics.
Clearance details
- Applicant
- Polymer Technology Systems, Inc. D/B/A Pts Diagnostics
- Product code
- Code CGA
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Indianapolis, IN, US
Adverse events under product code CGA
product code CGA- Death
- 2
- Malfunction
- 1,816
- Total
- 1,818
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.