Panels › Hematology › Product code GLK · Class 2
Control, Hematocrit
Regulation 864.8625
0510(k)s in 12 months (7 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in GLK
| Company | 510(k)s | Recalls |
|---|---|---|
| Aalto Scientific, Ltd. | 1 | 0 |
| Bionostics, Inc. | 1 | 0 |
| Ciba Corning Diagnostics Corp. | 1 | 0 |
| Eurotrol B.V. | 1 | 0 |
| Johnson & Johnson Professionals, Inc. | 1 | 0 |
| Medical Specialties, Inc. | 1 | 0 |
| Richmond Diagnostics, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 10, 2013 | K121467 | EUROTROL HEMATOCRIT CONTROL Eurotrol B.V., NL | GLK |
| Jun 24, 2002 | K021924 | MEDICA EASYQC HEMATOCRIT CONTROL Bionostics, Inc. | GLK |
| May 14, 2002 | K020618 | AALTO SCIENTIFIC MIRCO HEMATOCRIT CONTROL Aalto Scientific, Ltd. | GLK |
| Feb 20, 1997 | K964452 | HEMATACHEK Richmond Diagnostics, Inc. | GLK |
| Jul 26, 1996 | K961807 | CERTAIN HCT LEVEL A & LEVEL B/CVM HCT LEVELS 1,2,3, & 4 Ciba Corning Diagnostics Corp. | GLK |
| Jan 7, 1993 | K924926 | MSI-HCT Medical Specialties, Inc. | GLK |
| Jul 14, 1989 | K893562 | A.QC HCT LEVEL 1 AND 2 Johnson & Johnson Professionals, Inc. | GLK |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.