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. Device class: 2.
Clearance details
- Applicant
- Polymer Technology Systems, Inc. D/B/A Pts Diagnostics
- 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
- Special
- Location
- Indianapolis, IN, US
Recent devices under product code CGA
view allMore clearances from Polymer Technology Systems, Inc. D/B/A Pts Diagnostics
view allAdverse 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 →
Recalls naming K162282
K-number listed on FDA's recall record- Z-1741-2022 — PTS Panels CHOL+GLU Test Strips (REF 1765)
- Z-0741-2020 — PTS Panels CHOL+HDL+GLU Test Strips, Reference Number 5412, for use on CardioChek PA or CardioChek Plus analyzers
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K162282.
Data sourced from openFDA. This site is unofficial and independent of the FDA.