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.. Device class: 2.
Clearance details
- Applicant
- Polymer Technology Systems, Inc.
- Product code
- Code NBW
- Device class
- Class 2
- Regulation
- 21 CFR 862.1345
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Indianapolis, IN, US
Recent devices under product code NBW
view all- K260545 — CONTOUR® PLUS BLUE Blood Glucose Monitoring System +2 more
- K262116 — TRUE METRIX Self Monitoring Blood Glucose System
- K250085 — On Call® Sure GK Blood Glucose & Ketone Monitoring System +1 more
- K243060 — TeleRPM Gen2 Blood Glucose Monitoring System
- K240637 — RIGHTEST Blood Glucose Monitoring System Max Tel
More 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
- K151530 — CardioChek Plus 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 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 →
Recalls naming K140068
K-number listed on FDA's recall record- Z-0832-2020 — PTS Diagnostics CardioChek Plus Professional Analyzer, New analyzer, boxed, with carrying case, Reference Numbers 2700
- Z-0833-2020 — PTS Diagnostics CardioChek Plus Professional Analyzer, Refurbished analyzer, without box or carrying case, Reference Numbers 2702
- Z-0834-2020 — Henry Schein CardioChek Starter Kit, Reference Number 4060 HS, 570-1036
- Z-0835-2020 — Henry Schein CardioChek Plus Professional Analyzer, New Analyzer, boxed, with carrying case, Reference Number 4060 HS, 570-0411
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K140068.
Data sourced from openFDA. This site is unofficial and independent of the FDA.