CARDIOCHEK PLUS TEST SYSTEM, CARDIOCHEK HOME TEST SYSTEM— 510(k) K140068
Substantially EquivalentPolymer Technology Systems, Inc.
FDA 510(k) clearance K140068 for CARDIOCHEK PLUS TEST SYSTEM, CARDIOCHEK HOME TEST SYSTEM, Substantially Equivalent on 2015-05-22. Applicant: Polymer Technology Systems, Inc..
Clearance details
- Applicant
- Polymer Technology Systems, Inc.
- Product code
- Code NBW
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Indianapolis, IN, US
Adverse events under product code NBW
product code NBW- Death
- 18
- Injury
- 4,740
- Malfunction
- 42,679
- Other
- 6
- Total
- 47,443
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.