CardioChek Plus Test System— 510(k) K151530
Substantially EquivalentPolymer Technology Systems, Inc.
FDA 510(k) clearance K151530 for CardioChek Plus Test System, Substantially Equivalent on 2015-07-07. Applicant: Polymer Technology Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Polymer Technology Systems, Inc.
- Product code
- Code CGA
- Device class
- Class 2
- Regulation
- 21 CFR 862.1345
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Indianapolis, IN, US
Recent devices under product code CGA
view allMore clearances from Polymer Technology Systems, Inc.
view all- K151545 — CardioChek Plus Test System, CardioChek Home Test System, CardioChek PA Test System, CardioChek PA Home Test System
- K140068 — CARDIOCHEK PLUS TEST SYSTEM, CARDIOCHEK HOME TEST SYSTEM
- K142302 — BioScanner Plus Glucose Test System, PTS PANELS Chol+Glu Test Panel System, PTS PANELS Lipid Panel Test System, PTS PANELS HDL Cholesterol Test System, PTS PANELS CHOL+HDL Test System, PTS PANELS CHOL+HDL+GLU Panel Test System, PTS PANELS Metabolic Chemistry Panel Test System
- K071593 — PTS PANELS CHOL+HDL PANEL TEST STRIPS
- K071507 — PTS PANELS CHOL+HDL+GLU PANEL TEST STRIPS
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.