KQC · Stains, Hematology
Hematology · 21 CFR 864.1850 · Class 1
Overview
| Product Code | KQC |
|---|---|
| Device Name | Stains, Hematology |
| 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 (9 of 9)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K882873 | FIELDTEX HEMATOXYLIN | Anatech, Ltd. | Jul 28, 1988 | SESE |
| K852843 | GENERAL DIAGNOSTICS COAG-A-MATE XC | Warner-Lambert Co. | Aug 13, 1985 | SESE |
| K843619 | RETIC-SET | R&D Systems, Inc. | Oct 30, 1984 | SESE |
| K841848 | RETIC-SET | R&D Systems, Inc. | May 31, 1984 | SESE |
| K792550 | PONCEAU S STAIN SET | Electrophoresis Corp. of America | Jan 16, 1980 | SESE |
| K792496 | VOLU-SOL NMB RETICULOCYTE STAIN | Volu Sol Medical Industries | Dec 31, 1979 | SESE |
| K791007 | STAT DIFF STAIN | Bioscientific | Aug 3, 1979 | SESE |
| K760487 | HEMASTAIN PHOSPHATE BUFFER | Geometric Data, Div. Smithkline Corp. | Aug 30, 1976 | SESE |
| K760485 | HEMASTAIN FIXATIVE | Geometric Data, Div. Smithkline Corp. | Aug 30, 1976 | SESE |
Top Applicants
- Geometric Data, Div. Smithkline Corp. — 2 clearances
- R&D Systems, Inc. — 2 clearances
- Anatech, Ltd. — 1 clearance
- Bioscientific — 1 clearance
- Electrophoresis Corp. of America — 1 clearance
