HYJ · Hematoxylin
Hematology · 21 CFR 864.1850 · Class 1
Overview
| Product Code | HYJ |
|---|---|
| Device Name | Hematoxylin |
| 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 (14 of 14)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K872500 | ANATECH HEMATOXYLIN-EXTRA STRENGTH | Anatech, Ltd. | Jul 9, 1987 | SESE |
| K872499 | ANATECH HEMATOXYLIN-NORMAL STRENGTH | Anatech, Ltd. | Jul 9, 1987 | SESE |
| K842740 | DELAFIELD HEMATOXYLIN STAIN | E K Ind., Inc. | Aug 17, 1984 | SESE |
| K842741 | GILL HEMATOXYLIN STAIN | E K Ind., Inc. | Aug 15, 1984 | SESE |
| K831090 | HEMATOXYLIN GILL FORMULATION IX#56016 | Accra Laboratories, Inc. | Jun 8, 1983 | SESE |
| K822352 | HEMATOXYLIN STAIN SOLUTION | Fisher Scientific Co., LLC | Aug 16, 1982 | SESE |
| K821541 | HEMATOXYLIN III | Volu Sol Medical Industries | Jun 10, 1982 | SESE |
| K821540 | HEMATOXYLIN II | Volu Sol Medical Industries | Jun 10, 1982 | SESE |
| K821533 | HEMATOXYLIN I | Volu Sol Medical Industries | Jun 10, 1982 | SESE |
| K821320 | HEMATOXYLIN STAIN | Sigma Chemical Co. | Jun 2, 1982 | SESE |
| K821062 | HEMATOXYLIN SOLUTION | Sigma Chemical Co. | Apr 29, 1982 | SESE |
| K811802 | HEMATOXYLIN | Richard-Allan Medical Ind., Inc. | Jul 28, 1981 | SESE |
| K810759 | GILL'S HEMATOXYLIN #2 | Surgipath | Apr 14, 1981 | SESE |
| K810758 | GILL'S HEMATOXYLIN #1 | Surgipath | Apr 14, 1981 | SESE |
Top Applicants
- Volu Sol Medical Industries — 3 clearances
- Anatech, Ltd. — 2 clearances
- E K Ind., Inc. — 2 clearances
- Sigma Chemical Co. — 2 clearances
- Surgipath — 2 clearances
