Panels › Hematology › Product code GGM · Class 2
Control, Hemoglobin
Regulation 864.8625
0510(k)s in 12 months (15 all time)
0recalls in 12 months (2 all time)
2recalls that name a 510(k)
Top companies in GGM
| Company | 510(k)s | Recalls |
|---|---|---|
| Eurotrol B.V. | 2 | 2 |
| R&D Systems, Inc. | 3 | 0 |
| Bio-Rad | 2 | 0 |
| Direct Solutions | 2 | 0 |
| Bio-Rad Laboratories | 1 | 0 |
| Boehringer Mannheim Corp. | 1 | 0 |
| Dade, Baxter Travenol Diagnostics, Inc. | 1 | 0 |
| Electrophoresis Corp. | 1 | 0 |
| Isolab, Inc. | 1 | 0 |
| Quantimetrix Corp. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 15, 2019 | K192842 | HemoTrol Duo Low, HemoTrol Duo Normal, HemoTrol Duo High Eurotrol B.V., NL | GGM |
| Feb 1, 2019 | K182744 | HemoTrol WB - Low, HemoTrol WB - Normal, HemoTrol WB - High Eurotrol B.V., NL | GGM |
| Apr 2, 2007 | K070546 | LYPHOCHEK DIABETES CONTROL Bio-Rad Laboratories | GGM |
| Mar 29, 2007 | K070334 | R&D SICKLE QC CONTROL R&D Systems, Inc. | GGM |
| Nov 9, 2005 | K052838 | LIQUICHEK DIABETES CONTROL, LEVEL 1,2,3,4 Bio-Rad | GGM |
| Oct 30, 2003 | K032791 | GLYCOHEMOSURE HBA1C CONTROL Quantimetrix Corp. | GGM |
| Nov 29, 2000 | K003030 | LYPHOCHEK HEMOGLOBIN ALC LINEARITY SET Bio-Rad | GGM |
| Nov 12, 1999 | K993321 | R&D HGB/GLC WHOLE BLOOD CONTROL R&D Systems, Inc. | GGM |
| Nov 6, 1996 | K964052 | HEMOCUE HEMOTROL Direct Solutions | GGM |
| Oct 16, 1996 | K963908 | HEMOCUE HEMOLIN Direct Solutions | GGM |
| Nov 17, 1992 | K921681 | CRITERION, HEMOCUE B-HEMOGLOBIN CONTROL Isolab, Inc. | GGM |
| Aug 15, 1989 | K893985 | HGB-CONTROL SET/MULTIPLE R&D Systems, Inc. | GGM |
| Jul 5, 1985 | K852136 | PRECINORM HB Boehringer Mannheim Corp. | GGM |
| Mar 5, 1980 | K800296 | WHOLE BLOOD GAS CONTROL, LEVELS 1,2,&3 Dade, Baxter Travenol Diagnostics, Inc. | GGM |
| Mar 21, 1979 | K790310 | HEMOGLOBIN CONTROLS Electrophoresis Corp. | GGM |
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