BIOSCANNER 2000— 510(k) K013068

Substantially Equivalent

Polymer Technology Systems, Inc.

FDA 510(k) clearance K013068 for BIOSCANNER 2000, Substantially Equivalent on 2001-11-20. Applicant: Polymer Technology Systems, Inc..

Clearance details

Applicant: Polymer Technology Systems, Inc.
Product code: Code CGA
Advisory panel: Clinical Chemistry
Date received: 2001-06-28
Decision date: 2001-11-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

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 →

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