HYI
6 FDA 510(k) clearances · Product code
27 daysmedian time to decision
50 days90th percentile
6clearances measured
FDA profile
- Official device name
- Iodine, Grams
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 864.1850
- Medical specialty
- Hematology
- Flags
- GMP exempt
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| GRAM IODINE (K871286) | Remel Co. | 1987-04-08 |
| GRAM IODINE (K842733) | E K Ind., Inc. | 1984-08-10 |
| GRAMSTAIN SET (K821977) | Granite Diagnostics, Inc. | 1982-07-22 |
| PARA-PAK (K811722) | Meridian Diagnostics, Inc. | 1981-07-15 |
| IMPROVED GRAM STAIN REAGENTS (K791711) | Carr-Scarborough Microbiologicals, Inc. | 1979-10-17 |
| GRAM STAIN KIT (K781584) | Bioscientific | 1978-10-10 |
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Every clearance here is in the API, with alerts when new ones post.