HYF — Giemsa Stain Class I
FDA product code HYF covers "Giemsa Stain", a Class I medical device regulated under 21 CFR 864.1850. Submissions are reviewed by the Hematology panel. At least 4 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- HYF
- Device Class
- Class I
- Regulation Number
- 864.1850
- Submission Type
- Review Panel
- PA
- Medical Specialty
- Hematology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K842742 | e k ind | GIEMSA STAIN | August 15, 1984 |
| K833677 | j.s. medical assoc | QUICK STAIN WRIGHT'S GIEMSA W/BUFF | November 25, 1983 |
| K833665 | j.s. medical assoc | HEMATOLOGY WRIGHT'S-GIEMSA SATIN PACK | November 25, 1983 |
| K831131 | case instruments | CASE WRIGHT-GIEMSA STAIN PAK | June 8, 1983 |