HYB — Eosin Y Class I
FDA product code HYB covers "Eosin Y", a Class I medical device regulated under 21 CFR 864.1850. Submissions are reviewed by the Hematology panel. At least 10 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- HYB
- 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 |
|---|---|---|---|
| K893663 | shandon | INSTANT EOSIN-AQUEOUS | June 13, 1989 |
| K880596 | sigma chemical | EOSIN Y SOLUTION, ALCOHOLIC, WITH PHLOXINE | March 31, 1988 |
| K880240 | shandon | INSTANT EOSIN-ALCOHOLIC | March 3, 1988 |
| K843426 | accra laboratories | EOSIN Y 1% ALCOHOLIC | September 27, 1984 |
| K822982 | emd chemicals | MIDAS 100 HEMACOLOR STAIN #66030 | October 27, 1982 |
| K821574 | sigma chemical | EOSIN Y SOLUTIN, AGUEOUS | June 10, 1982 |
| K821573 | sigma chemical | EOSIN Y SOLUTION ALCHOLIC | June 9, 1982 |
| K811797 | richard-allan medical ind | EOSIN-Y | July 28, 1981 |
| K811826 | surgipath | EOSIN Y | July 10, 1981 |
| K800942 | volu sol medical industries | VOLU-SOL EOSIN Y STAIN | May 8, 1980 |