HemoCue® Plasma/Low Hb Microcuvettes
HemoCue Plasma/Low Hb Microcuvettes 4x25 vial
1manufacturer
1catalogue number
6510(k) clearances naming this product code
1recall
Who Else Makes It
Registered in Zhejiang. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Acon Biotech (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 29 |
Record
| Listed by | Hemocue AB, Sweden |
|---|---|
| FDA product code | GKR |
| Device type | System, Hemoglobin, Automated |
| Device class | Class 2 |
| Regulation | 21 CFR 864.5620 |
| Establishment | Manufacturer |
| 510(k) | BK000043 |
| Record published | 2016-05-27 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Do not refrigerate; Storage environment temperature 59 to 86 °F; Storage environment temperature 15 to 30 °C |
| Packaging | Package of 4 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 110302 | 25 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| RAPIDPoint® 405/500 Measurement Cartridge | Siemens Healthcare Diagnostics Inc | 8 |
| McKesson | Mckesson Medical-Surgical Inc. | 6 |
| HemoCue® Hb 301 Microcuvettes | Hemocue AB | 5 |
| HemoCue® Hb 201 Microcuvettes | Hemocue AB | 4 |
| Henry Schein | Henry Schein, Inc. | 4 |
| Mission Plus Hemoglobin (Hb) Monitoring System | Acon Laboratories, Inc. | 3 |
| Mission Plus Hemoglobin (Hb) Test Cartridges | Acon Laboratories, Inc. | 3 |
| DiaSpect Tm | EKF Diagnostic Gmbh | 2 |
| HemoCue® Hb 201+ Analyzer | Hemocue AB | 2 |
| Mission Capillary Transfer Tubes | Acon Laboratories, Inc. | 2 |
| Mission Plus Hemoglobin (Hb) Optical Verifier | Acon Laboratories, Inc. | 2 |
| HemoCue® Hb301 Analyzer | Hemocue AB | 2 |
Showing 12 of 43. All products under System, Hemoglobin, Automated
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K201217 | 2020-08-04 |
| K181751 | 2019-02-01 |
| K061047 | 2006-06-08 |
| K041234 | 2004-06-10 |
| K032203 | 2003-08-25 |
| K961312 | 1996-09-24 |
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2013-07-25 | Class II | Packaging | HemoCue AB has become aware of a production related problem involving punctured HemoCue Hb 201 Microcuvettes single pack pouches. | 42,330 packages/4 boxes/25 microcuvetes | 2014-08-11 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.