HYI · Iodine, Grams
Hematology · 21 CFR 864.1850 · Class 1
Overview
| Product Code | HYI |
|---|---|
| Device Name | Iodine, Grams |
| Regulation | 21 CFR 864.1850 |
| Device Class | Class 1 |
| Review Panel | Hematology |
| GMP Exempt | Yes |
Identification
Dye and chemical solution stains for medical purposes are mixtures of synthetic or natural dyes or nondye chemicals in solutions used in staining cells and tissues for diagnostic histopathology, cytopathology, or hematology.
Classification Rationale
Class I (general controls). These devices are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9. These devices are also exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.
Recent Cleared Devices (6 of 6)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K871286 | GRAM IODINE | Remel Co. | Apr 8, 1987 | SESE |
| K842733 | GRAM IODINE | E K Ind., Inc. | Aug 10, 1984 | SESE |
| K821977 | GRAMSTAIN SET | Granite Diagnostics, Inc. | Jul 22, 1982 | SESE |
| K811722 | PARA-PAK | Meridian Diagnostics, Inc. | Jul 15, 1981 | SESE |
| K791711 | IMPROVED GRAM STAIN REAGENTS | Carr-Scarborough Microbiologicals, Inc. | Oct 17, 1979 | SESE |
| K781584 | GRAM STAIN KIT | Bioscientific | Oct 10, 1978 | SESE |
Top Applicants
- Bioscientific — 1 clearance
- Carr-Scarborough Microbiologicals, Inc. — 1 clearance
- E K Ind., Inc. — 1 clearance
- Granite Diagnostics, Inc. — 1 clearance
- Meridian Diagnostics, Inc. — 1 clearance
