510(k) K020935 ยท CGA Glucose Oxidase, Glucose
HEMOCUE GLUCOSE 201 SYSTEM, ARTICLE NUMBER 120706
| Applicant | Hemocue, Inc., Potomac MD, US |
| Decision | Substantially Equivalent, Apr 3, 2002 |
| Received | Mar 22, 2002 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K020935
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 2, 2025 | HemoCue AB The HemoCue Glucose 201 Microcuvettes are designed for use with the HemoCue Glucose 201 (or DM) Analyzer with plasma conversion that multiplies the measured whole blood glucose value by a factor of 1. Open, Classified |
CGA | None listed |
| Dec 24, 2014 | Radiometer America Inc HemoCue Glucose 201 Microcuvettes, The HemoCue Glucose 201 Microcuvettes are designed for use with the HemoCue Glucose 201Analyzer and the HemoCue Glucose 201 DM Analyzer (hereafter referred to as the Terminated |
CGA | None listed |
| Sep 11, 2013 | HemoCue AB HemoCue Glucose 201 Microcuvettes, 25 Microcuvettes Individually Packaged.
The HemoCue Glucose 201 Microcuvettes are designed for use with the HemoCue Glucose 201 Analyzer and the HemoCue Glucose 2 Terminated |
CGA | None listed |
| Jan 20, 2012 | Hemo Cue, Inc. HemoCue Glucose 201 Microcuvettes,
Article Number:110705*,110706,110715**,110716**,110717**,110718**,
110719**
" No affected lots of this article have been delivered to customers. Still
in stock a Terminated |
CGA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.