PTS Professional Chemistry Kit— 510(k) K182781

Name: FDA 510(k) clearance K182781
Creator: U.S. Food and Drug Administration
Published: 2018-12-21

Unknown

Polymer Technology Systems, Inc. D/B/A Pts Diagnostics

FDA 510(k) clearance K182781 for PTS Professional Chemistry Kit, Unknown on 2018-12-21. 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: 2018-10-01
Decision date: 2018-12-21
Decision: Unknown
Clearance type: Traditional
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code CGA

product code CGA

Death: 2
Malfunction: 1,816
Total: 1,818

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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 K182781

K-number listed on FDA's recall record

Z-1373-2019 — CHOL+HDL+GLU test strips, REF 2412Class II·Terminated·Polymer Technology Systems, Inc.·20190116

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K182781.

Data sourced from openFDA. This site is unofficial and independent of the FDA.