GGM — Control, Hemoglobin Class II
FDA product code GGM covers "Control, Hemoglobin", a Class II medical device regulated under 21 CFR 864.8625. Submissions are reviewed by the Hematology panel. At least 15 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- GGM
- Device Class
- Class II
- Regulation Number
- 864.8625
- Submission Type
- Review Panel
- HE
- Medical Specialty
- Hematology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K192842 | eurotrol | HemoTrol Duo Low, HemoTrol Duo Normal, HemoTrol Duo High | November 15, 2019 |
| K182744 | eurotrol | HemoTrol WB - Low, HemoTrol WB - Normal, HemoTrol WB - High | February 1, 2019 |
| K070546 | bio-rad laboratories | LYPHOCHEK DIABETES CONTROL | April 2, 2007 |
| K070334 | r and d systems | R&D SICKLE QC CONTROL | March 29, 2007 |
| K052838 | bio-rad | LIQUICHEK DIABETES CONTROL, LEVEL 1,2,3,4 | November 9, 2005 |
| K032791 | quantimetrix | GLYCOHEMOSURE HBA1C CONTROL | October 30, 2003 |
| K003030 | bio-rad | LYPHOCHEK HEMOGLOBIN ALC LINEARITY SET | November 29, 2000 |
| K993321 | r and d systems | R&D HGB/GLC WHOLE BLOOD CONTROL | November 12, 1999 |
| K964052 | direct solutions | HEMOCUE HEMOTROL | November 6, 1996 |
| K963908 | direct solutions | HEMOCUE HEMOLIN | October 16, 1996 |
| K921681 | isolab | CRITERION, HEMOCUE B-HEMOGLOBIN CONTROL | November 17, 1992 |
| K893985 | r and d systems | HGB-CONTROL SET/MULTIPLE | August 15, 1989 |
| K852136 | boehringer mannheim | PRECINORM HB | July 5, 1985 |
| K800296 | dade, baxter travenol diagnostics | WHOLE BLOOD GAS CONTROL, LEVELS 1,2,&3 | March 5, 1980 |
| K790310 | electrophoresis | HEMOGLOBIN CONTROLS | March 21, 1979 |