KFC — Methylene Blue, Tissue Stain Class I
FDA product code KFC covers "Methylene Blue, Tissue Stain", a Class I medical device regulated under 21 CFR 864.1850. Submissions are reviewed by the Hematology panel. At least 7 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- KFC
- 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 |
|---|---|---|---|
| K875310 | sigma diagnostics | RETICULOCYTE STAIN | February 9, 1988 |
| K843919 | difco laboratories | SPOTTEST LOEFFLER METHYLENE BLUE STAIN | October 30, 1984 |
| K842926 | e k ind | METHYLENE BLUE STAIN, LOEFFLER | September 11, 1984 |
| K842785 | reagent laboratory | STAIN, METHYLENE BLUE-EOSIN | September 11, 1984 |
| K842743 | e k ind | NEW METHYLENE BLUE N | August 12, 1984 |
| K831502 | flaitron laboratories | NEPHROLYTE | July 18, 1983 |
| K770792 | corning medical and scientific | TUBE, STAIN, RETICULOCYTE, LARC | July 5, 1977 |