KFC · Methylene Blue, Tissue Stain
Hematology · 21 CFR 864.1850 · Class 1
Overview
| Product Code | KFC |
|---|---|
| Device Name | Methylene Blue, Tissue Stain |
| 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 |
|---|---|---|---|---|
| K875310 | RETICULOCYTE STAIN | Sigma Diagnostics, Inc. | Feb 9, 1988 | SESE |
| K843919 | SPOTTEST LOEFFLER METHYLENE BLUE STAIN | Difco Laboratories, Inc. | Oct 30, 1984 | SESE |
| K842926 | METHYLENE BLUE STAIN, LOEFFLER | E K Ind., Inc. | Sep 11, 1984 | SESE |
| K842785 | STAIN, METHYLENE BLUE-EOSIN | Reagent Laboratory, Inc. | Sep 11, 1984 | SESE |
| K842743 | NEW METHYLENE BLUE N | E K Ind., Inc. | Aug 12, 1984 | SESE |
| K831502 | NEPHROLYTE | Flaitron Laboratories, Inc. | Jul 18, 1983 | SESE |
| K770792 | TUBE, STAIN, RETICULOCYTE, LARC | Corning Medical & Scientific | Jul 5, 1977 | SESE |
Top Applicants
- E K Ind., Inc. — 2 clearances
- Corning Medical & Scientific — 1 clearance
- Difco Laboratories, Inc. — 1 clearance
- Flaitron Laboratories, Inc. — 1 clearance
- Reagent Laboratory, Inc. — 1 clearance
