HYI — Iodine, Grams Class I
FDA product code HYI covers "Iodine, Grams", a Class I medical device regulated under 21 CFR 864.1850. Submissions are reviewed by the Hematology panel. At least 6 recent 510(k) clearances have been granted under this product code.
Classification details
- Product Code
- HYI
- Device Class
- Class I
- Regulation Number
- 864.1850
- Submission Type
- 510(k) Exempt
- Review Panel
- PA
- Medical Specialty
- Hematology
- Implant
- No
Recent 510(k) clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K871286 | Remel | GRAM IODINE | Apr 8, 1987 |
| K842733 | E K Ind | GRAM IODINE | Aug 10, 1984 |
| K821977 | Granite Diagnostics | GRAMSTAIN SET | Jul 22, 1982 |
| K811722 | Meridian Diagnostics | PARA-PAK | Jul 15, 1981 |
| K791711 | Carr-Scarborough Microbiologicals | IMPROVED GRAM STAIN REAGENTS | Oct 17, 1979 |
| K781584 | Bioscientific | GRAM STAIN KIT | Oct 10, 1978 |