HYB · Eosin Y
Hematology · 21 CFR 864.1850 · Class 1
Overview
| Product Code | HYB |
|---|---|
| Device Name | Eosin Y |
| 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 (10 of 10)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K893663 | INSTANT EOSIN-AQUEOUS | Shandon, Inc. | Jun 13, 1989 | SESE |
| K880596 | EOSIN Y SOLUTION, ALCOHOLIC, WITH PHLOXINE | Sigma Chemical Co. | Mar 31, 1988 | SESE |
| K880240 | INSTANT EOSIN-ALCOHOLIC | Shandon, Inc. | Mar 3, 1988 | SESE |
| K843426 | EOSIN Y 1% ALCOHOLIC | Accra Laboratories, Inc. | Sep 27, 1984 | SESE |
| K822982 | MIDAS 100 HEMACOLOR STAIN #66030 | Emd Chemicals, Inc. | Oct 27, 1982 | SESE |
| K821574 | EOSIN Y SOLUTIN, AGUEOUS | Sigma Chemical Co. | Jun 10, 1982 | SESE |
| K821573 | EOSIN Y SOLUTION ALCHOLIC | Sigma Chemical Co. | Jun 9, 1982 | SESE |
| K811797 | EOSIN-Y | Richard-Allan Medical Ind., Inc. | Jul 28, 1981 | SESE |
| K811826 | EOSIN Y | Surgipath | Jul 10, 1981 | SESE |
| K800942 | VOLU-SOL EOSIN Y STAIN | Volu Sol Medical Industries | May 8, 1980 | SESE |
Top Applicants
- Sigma Chemical Co. — 3 clearances
- Shandon, Inc. — 2 clearances
- Accra Laboratories, Inc. — 1 clearance
- Emd Chemicals, Inc. — 1 clearance
- Richard-Allan Medical Ind., Inc. — 1 clearance
