GLK — Control, Hematocrit Class II
FDA Device Classification
Classification Details
- Product Code
- GLK
- Device Class
- Class II
- Regulation Number
- 864.8625
- Submission Type
- Review Panel
- HE
- Medical Specialty
- Hematology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K121467 | eurotrol | EUROTROL HEMATOCRIT CONTROL | May 10, 2013 |
| K021924 | bionostics | MEDICA EASYQC HEMATOCRIT CONTROL | June 24, 2002 |
| K020618 | aalto scientific | AALTO SCIENTIFIC MIRCO HEMATOCRIT CONTROL | May 14, 2002 |
| K964452 | richmond diagnostics | HEMATACHEK | February 20, 1997 |
| K961807 | ciba corning diagnostics | CERTAIN HCT LEVEL A & LEVEL B/CVM HCT LEVELS 1,2,3, & 4 | July 26, 1996 |
| K924926 | medical specialties | MSI-HCT | January 7, 1993 |
| K893562 | johnson and johnson professionals | A.QC HCT LEVEL 1 AND 2 | July 14, 1989 |