Product code GGM
- Device name
- Control, Hemoglobin
- Medical specialty
- Hematology
- Device class
- 2
- Regulation number
- 864.8625
- Review panel
- HE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K192842 | HemoTrol Duo Low, HemoTrol Duo Normal, HemoTrol Duo High | Eurotrol B.V. | 2019-11-15 |
| K182744 | HemoTrol WB - Low, HemoTrol WB - Normal, HemoTrol WB - High | Eurotrol B.V. | 2019-02-01 |
| K070546 | LYPHOCHEK DIABETES CONTROL | Bio-Rad Laboratories | 2007-04-02 |
| K070334 | R&D SICKLE QC CONTROL | R&D Systems, Inc. | 2007-03-29 |
| K052838 | LIQUICHEK DIABETES CONTROL, LEVEL 1,2,3,4 | Bio-Rad | 2005-11-09 |
| K032791 | GLYCOHEMOSURE HBA1C CONTROL | Quantimetrix Corp. | 2003-10-30 |
| K003030 | LYPHOCHEK HEMOGLOBIN ALC LINEARITY SET | Bio-Rad | 2000-11-29 |
| K993321 | R&D HGB/GLC WHOLE BLOOD CONTROL | R&D Systems, Inc. | 1999-11-12 |
| K964052 | HEMOCUE HEMOTROL | Direct Solutions | 1996-11-06 |
| K963908 | HEMOCUE HEMOLIN | Direct Solutions | 1996-10-16 |
| K921681 | CRITERION, HEMOCUE B-HEMOGLOBIN CONTROL | Isolab, Inc. | 1992-11-17 |
| K893985 | HGB-CONTROL SET/MULTIPLE | R&D Systems, Inc. | 1989-08-15 |
| K852136 | PRECINORM HB | Boehringer Mannheim Corp. | 1985-07-05 |
| K800296 | WHOLE BLOOD GAS CONTROL, LEVELS 1,2,&3 | Dade, Baxter Travenol Diagnostics, Inc. | 1980-03-05 |
| K790310 | HEMOGLOBIN CONTROLS | Electrophoresis Corp. | 1979-03-21 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 08718734962649 | CueSee® CO-OX | Eurotrol B.V. | 2025-01-23 |
| 08718734961598 | CueSee® CO-OX | Eurotrol B.V. | 2021-12-19 |
| 08718734961581 | CueSee® CO-OX | Eurotrol B.V. | 2021-12-19 |
| 08718734961574 | CueSee® CO-OX | Eurotrol B.V. | 2021-12-19 |
| 08718734961567 | CueSee® CO-OX | Eurotrol B.V. | 2021-12-19 |
| 08718734961550 | CueSee® CO-OX | Eurotrol B.V. | 2021-12-19 |
| 08718734961024 | CueSee® CO-OX | Eurotrol B.V. | 2021-12-19 |
| 08718734961048 | CueSee® CO-OX | Eurotrol B.V. | 2021-12-19 |
| 14048534001998 | DiaSpect Control HBT3 | EKF-diagnostic GmbH | 2021-03-12 |
| 14048534001981 | DiaSpect Control HBT2 | EKF-diagnostic GmbH | 2021-03-12 |
| 14048534001974 | DiaSpect Control HBT1 | EKF-diagnostic GmbH | 2021-03-12 |
| 08718734961215 | HemoTrol Duo | Eurotrol B.V. | 2019-12-20 |
| 08718734961222 | HemoTrol Duo | Eurotrol B.V. | 2019-12-20 |
| 08718734961208 | HemoTrol Duo | Eurotrol B.V. | 2019-12-20 |
| 08718734960997 | HemoTrol WB | Eurotrol B.V. | 2019-03-18 |
| 08718734960980 | HemoTrol WB | Eurotrol B.V. | 2019-03-18 |
| 10304040103804 | Henry Schein | HENRY SCHEIN, INC. | 2019-01-11 |
| 08718734960232 | Eurotrol | Eurotrol B.V. | 2016-08-26 |
| 08718734960409 | Eurotrol | Eurotrol B.V. | 2016-08-26 |
| 08718734960386 | Eurotrol | Eurotrol B.V. | 2016-08-26 |
| 08718734960362 | Eurotrol | Eurotrol B.V. | 2016-08-26 |
| 08718734960348 | Eurotrol | Eurotrol B.V. | 2016-08-26 |
| 08718734960324 | Eurotrol | Eurotrol B.V. | 2016-08-26 |
| 08718734960300 | Eurotrol | Eurotrol B.V. | 2016-08-26 |
| 08718734960287 | Eurotrol | Eurotrol B.V. | 2016-08-26 |
| 08718734960263 | Eurotrol | Eurotrol B.V. | 2016-08-26 |
| 08718734960249 | Eurotrol | Eurotrol B.V. | 2016-08-26 |
| 10815762020954 | Research and Diagnostic Systems | RESEARCH AND DIAGNOSTIC SYSTEMS, INC. | 2016-07-29 |
| 10815762020978 | Research and Diagnostic Systems | RESEARCH AND DIAGNOSTIC SYSTEMS, INC. | 2016-07-29 |
| 10815762020992 | Research and Diagnostic Systems | RESEARCH AND DIAGNOSTIC SYSTEMS, INC. | 2016-07-29 |