HYK · Hematoxylin Harris'S
Hematology · 21 CFR 864.1850 · Class 1
Overview
| Product Code | HYK |
|---|---|
| Device Name | Hematoxylin Harris'S |
| 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 (7 of 7)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K873107 | INSTANT HEMATOXYLIN | Shandon, Inc. | Aug 21, 1987 | SESE |
| K872498 | HARRIS HEMATOXYLIN | Anatech, Ltd. | Jul 9, 1987 | SESE |
| K843425 | HARRIS HEMATOXYLIN, MERCURY FREE, ACID | Accra Laboratories, Inc. | Oct 2, 1984 | SESE |
| K823328 | HARRIS HEMATOXYLIN | Accra Laboratories, Inc. | Dec 28, 1982 | SESE |
| K810733 | HARRIS HEMATOXYLIN | Surgipath | Apr 14, 1981 | SESE |
| K800324 | VOLU-SOL HARRIS HEMATOXYLIN | Volu Sol Medical Industries | Feb 22, 1980 | SESE |
| K781585 | HEMATOXYLIN STAIN HARRIS | Bioscientific | Oct 10, 1978 | SESE |
Top Applicants
- Accra Laboratories, Inc. — 2 clearances
- Anatech, Ltd. — 1 clearance
- Bioscientific — 1 clearance
- Shandon, Inc. — 1 clearance
- Surgipath — 1 clearance
