510(k) K121467
- Device
- EUROTROL HEMATOCRIT CONTROL
- Applicant
- EUROTROL B.V.
- 510(k) number
- K121467
- Product code
- GLK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2013-05-10
- Date received
- 2012-05-17
- Regulation
- 864.8625
- Classification name
- Control, Hematocrit
- Medical specialty
- Hematology
- Review panel
- Hematology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- PAUL B.P. KOOIJMANS
- Address
- Keplerlaan 20 Ede NL 6716BS 6716BS
FDA Registration Numbers#
- 2248933
- 1616487
- 3005643513
- 3002637618
- 3003971136
- 1220649
- 3037000637
- 3014150341
- 2432235
- 2431530
- 3006198300
- 1217183
- 9681518
Source Documents#
Other 510(k) Records For Product Code GLK #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K021924 | MEDICA EASYQC HEMATOCRIT CONTROL | Bionostics, Inc. | 2002-06-24 |
| K020618 | AALTO SCIENTIFIC MIRCO HEMATOCRIT CONTROL | Aalto Scientific, Ltd. | 2002-05-14 |
| K964452 | HEMATACHEK | Richmond Diagnostics, Inc. | 1997-02-20 |
| K961807 | CERTAIN HCT LEVEL A & LEVEL B/CVM HCT LEVELS 1,2,3, & 4 | Ciba Corning Diagnostics Corp. | 1996-07-26 |
| K924926 | MSI-HCT | Medical Specialties, Inc. | 1993-01-07 |
| K893562 | A.QC HCT LEVEL 1 AND 2 | Johnson & Johnson Professionals, Inc. | 1989-07-14 |
Legacy Summary#
summary
FDA Review#
Decision Summary