FDA Product Code
FDA Product Code GLK — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Hematology
- 21 CFR Citation
- 864.8625
510(k) Clearances — 7 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K121467 | EUROTROL HEMATOCRIT CONTROL | Eurotrol B.V. | 2013-05-10 | Traditional | PDF ↗ |
| K021924 | MEDICA EASYQC HEMATOCRIT CONTROL | Bionostics, Inc. | 2002-06-24 | Traditional | PDF ↗ |
| K020618 | AALTO SCIENTIFIC MIRCO HEMATOCRIT CONTROL | Aalto Scientific, Ltd. | 2002-05-14 | Traditional | PDF ↗ |
| K964452 | HEMATACHEK | Richmond Diagnostics, Inc. | 1997-02-20 | Traditional | PDF ↗ |
| K961807 | CERTAIN HCT LEVEL A & LEVEL B/CVM HCT LEVELS 1,2,3, & 4 | Ciba Corning Diagnostics Corp. | 1996-07-26 | Traditional | PDF ↗ |
| K924926 | MSI-HCT | Medical Specialties, Inc. | 1993-01-07 | Traditional | PDF ↗ |
| K893562 | A.QC HCT LEVEL 1 AND 2 | Johnson & Johnson Professionals, Inc. | 1989-07-14 | Traditional | PDF ↗ |
Product code GLK · Class II · Hematology. Data: openFDA.