510(k) BK030067
- Device
- 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices
- Applicant
- HemoCue, Incorporated
- 510(k) number
- BK030067
- Product code
- GGM
- Decision
- Substantially Equivalent (SE)
- Decision date
- 2003-12-19
- Date received
- 2003-10-27
- Regulation
- 864.8625
- Classification name
- Control, Hemoglobin
- Medical specialty
- 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices
- Review panel
- 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices
- Clearance type
- 510(k) Traditio
- Third party reviewed
- No
Other 510(k) Records For Product Code GGM #
| 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 |
Legacy Summary#
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FDA Review#
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