GKX — Instrument, Automated Platelet Counting Class II
FDA Device Classification
Classification Details
- Product Code
- GKX
- Device Class
- Class II
- Regulation Number
- 864.5200
- Submission Type
- Review Panel
- HE
- Medical Specialty
- Hematology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K014203 | abx diagnostics | ABX MICROS 60 HEMATOLOGY ANALYZER | February 28, 2002 |
| K840948 | gainor medical | CLEAR POROUS PLASTIC-HYPOALLERGENIC | August 14, 1984 |