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 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 18, 2018 | EUROTROL INC HemoTrol Level 3- In Vitro Diagnostic Hematology quality control mixture.
Catalogue number: 171.003.002
Eurotrol HemoLin is an assayed hemoglobin control intended for professional use in the verifica Terminated |
GGM | K964052 |
| Oct 18, 2018 | EUROTROL INC HemoTrol Level 2- In Vitro Diagnostic Hematology quality control mixture
Catalogue number: 171.002.002
Eurotrol HemoLin is an assayed hemoglobin control intended for professional use in the verificat Terminated |
GGM | K964052 |
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