FDA Product Code
FDA Product Code GGM — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Hematology
- 21 CFR Citation
- 864.8625
510(k) Clearances — 15 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K192842 | HemoTrol Duo Low, HemoTrol Duo Normal, HemoTrol Duo High | Eurotrol B.V. | 2019-11-15 | Traditional | PDF ↗ |
| K182744 | HemoTrol WB - Low, HemoTrol WB - Normal, HemoTrol WB - High | Eurotrol B.V. | 2019-02-01 | Traditional | PDF ↗ |
| K070546 | LYPHOCHEK DIABETES CONTROL | Bio-Rad Laboratories | 2007-04-02 | Traditional | PDF ↗ |
| K070334 | R&D SICKLE QC CONTROL | R&D Systems, Inc. | 2007-03-29 | Traditional | PDF ↗ |
| K052838 | LIQUICHEK DIABETES CONTROL, LEVEL 1,2,3,4 | Bio-Rad | 2005-11-09 | Traditional | PDF ↗ |
| K032791 | GLYCOHEMOSURE HBA1C CONTROL | Quantimetrix Corp. | 2003-10-30 | Traditional | PDF ↗ |
| K003030 | LYPHOCHEK HEMOGLOBIN ALC LINEARITY SET | Bio-Rad | 2000-11-29 | Traditional | PDF ↗ |
| K993321 | R&D HGB/GLC WHOLE BLOOD CONTROL | R&D Systems, Inc. | 1999-11-12 | Traditional | PDF ↗ |
| K964052 | HEMOCUE HEMOTROL | Direct Solutions | 1996-11-06 | Traditional | PDF ↗ |
| K963908 | HEMOCUE HEMOLIN | Direct Solutions | 1996-10-16 | Traditional | PDF ↗ |
| K921681 | CRITERION, HEMOCUE B-HEMOGLOBIN CONTROL | Isolab, Inc. | 1992-11-17 | Traditional | PDF ↗ |
| K893985 | HGB-CONTROL SET/MULTIPLE | R&D Systems, Inc. | 1989-08-15 | Traditional | PDF ↗ |
| K852136 | PRECINORM HB | Boehringer Mannheim Corp. | 1985-07-05 | Traditional | PDF ↗ |
| K800296 | WHOLE BLOOD GAS CONTROL, LEVELS 1,2,&3 | Dade, Baxter Travenol Diagnostics, Inc. | 1980-03-05 | Traditional | PDF ↗ |
| K790310 | HEMOGLOBIN CONTROLS | Electrophoresis Corp. | 1979-03-21 | Traditional | PDF ↗ |
Product code GGM · Class II · Hematology. Data: openFDA.