Company ยท US
Hemocue, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1991 to 2020. Name variants (Inc, Corp, punctuation) are merged.
15510(k) clearances (0 in 12 months)
5recalls (0 in 12 months)
5recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 4, 2020 | K201217 | HemoCue Hb 301 System Hemocue AB, SE | GKR |
| Feb 1, 2019 | K181751 | HemoCue Hb 801 System Hemocue AB, SE | GKR |
| Oct 25, 2007 | K071652 | HEMOCUE WBC SYSTEM Hemocue AB | GKL |
| Sep 6, 2006 | K060765 | HEMOCUE GLUCOSE 201 RT ANALYZER MDL 120731, HEMOCUE GLUCOSE 201 RT MICROCURETTES MDL 110712 Hemocue AB | LFR |
| Jun 8, 2006 | K061047 | HEMOCUE HB 301 ANALYZER, MODEL 121804 AND MICROCUVETTES, MODEL 111801 Hemocue AB | GKR |
| Feb 17, 2006 | K053253 | HEMOCUE ALBUMIN 201 ANALYZING SYSTEM Hemocue AB | KQO |
| Jun 10, 2004 | K041234 | HEMOCUE HEMOGLOBIN 201DM ANALYZING SYSTEM Hemocue, Inc. | GKR |
| May 20, 2004 | K041230 | CLINICAL LABORATORY ANALYZING SYSTEM Hemocue, Inc. | LFR |
| Aug 25, 2003 | K032203 | HEMOCUE HEMOGLOBIN 201 + SYSTEM ARTICLE 121704 Hemocue, Inc. | GKR |
| Apr 3, 2002 | K020935 | HEMOCUE GLUCOSE 201 SYSTEM, ARTICLE NUMBER 120706 Hemocue, Inc. | CGA |
| Oct 15, 1996 | K962415 | HEMOCUE B-GLCOSE SYSTEM Hemocue, Inc. | LFR |
| Sep 24, 1996 | K961312 | HEMOCUE B-HEMOGLOBIN SYSTEM Hemocue, Inc. | GKR |
| Aug 23, 1996 | K961311 | HEMOCUE B-GLUCOSE SYSTEM Hemocue, Inc. | LFR |
| Jan 17, 1995 | K943432 | HEMOCUE B-GLUCOSE SYSTEM Hemocue, Inc. | CGA |
| May 8, 1991 | K911141 | HEMOCUE(R) B-GLUCOSE MICROCUVETTE/PHOTOMETER Hemocue, Inc. | CGA |
Latest recalls
| 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 | K020935 |
| Oct 29, 2013 | HemoCue AB HemoCue Hb 201 Microcuvettes, carton/4 boxes/25 pouches of Microcuvettes, HemoCue AB Angelholm, Sweden Terminated |
GKR | K032203 |
| Oct 25, 2013 | HemoCue AB HemoCue Urine Albumin Microcuvettes, 25 Microcuvettes HemoCue AB Angelholm, Sweden
The quantitative, rapid, turbidimetric immunoassay of albumin in human urine using a specially designed analyzer, th Terminated |
KQO | K053253 |
| 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 | K020935 |
| Dec 28, 2012 | HemoCue AB Analyzing system consists of a small and portable analyzer and plastic microcuvettes. The microcuvette contains reagents deposited on its inner walls. The urine sample is drawn into the cavity by capi Terminated |
JIQ | K053253 |