Iodine, Grams
FDA product code HYI · Class I (low risk) · 21 CFR 864.1850 · Hematology
6510(k) clearances
0PMA approvals
0recalls
GMP exemptexempt from GMP rules
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K871286 | Gram IodineHYI · Traditional | Remel Co. | 04/08/1987SE |
| K842733 | Gram IodineHYI · Traditional | E K Ind., Inc. | 08/10/1984SE |
| K821977 | Gramstain SetHYI · Traditional | Granite Diagnostics, Inc. | 07/22/1982SE |
| K811722 | Para-PakHYI · Traditional | Meridian Diagnostics, Inc. | 07/15/1981SE |
| K791711 | Improved Gram Stain ReagentsHYI · Traditional | Carr-Scarborough Microbiologicals, Inc. | 10/17/1979SE |
| K781584 | Gram Stain KitHYI · Traditional | Bioscientific | 10/10/1978SE |