GLK
7 FDA 510(k) clearances · Product code
78 daysmedian time to decision
358 days90th percentile
7clearances measured
FDA profile
- Official device name
- Control, Hematocrit
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.8625
- Medical specialty
- Hematology
- Adverse events (MAUDE)
- 2002: 1 · 2005: 2 · 2007: 2
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| EUROTROL HEMATOCRIT CONTROL (K121467) | Eurotrol B.V. | 2013-05-10 |
| MEDICA EASYQC HEMATOCRIT CONTROL (K021924) | Bionostics, Inc. | 2002-06-24 |
| AALTO SCIENTIFIC MIRCO HEMATOCRIT CONTROL (K020618) | Aalto Scientific, Ltd. | 2002-05-14 |
| HEMATACHEK (K964452) | Richmond Diagnostics, Inc. | 1997-02-20 |
| CERTAIN HCT LEVEL A & LEVEL B/CVM HCT LEVELS 1,2,3, & 4 (K961807) | Ciba Corning Diagnostics Corp. | 1996-07-26 |
| MSI-HCT (K924926) | Medical Specialties, Inc. | 1993-01-07 |
| A.QC HCT LEVEL 1 AND 2 (K893562) | Johnson & Johnson Professionals, Inc. | 1989-07-14 |
Track GLK automatically
Every clearance here is in the API, with alerts when new ones post.