Product code HYG
- Device name
- Glenner'S Stain
- Medical specialty
- Hematology
- Device class
- 1
- Regulation number
- 864.1850
- Review panel
- PA
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- Y
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K802690 | ULTRAPAK CAT. #100-0251 | Occumedics, Inc. | 1981-01-08 |