ICL · Carbol Fuchsin
Hematology · 21 CFR 864.1850 · Class 1
Overview
| Product Code | ICL |
|---|---|
| Device Name | Carbol Fuchsin |
| 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 (4 of 4)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K890148 | ATS TB RAPID STAIN SET PRODUCT #034-45 | Alpha-Tec Systems, Inc. | Jan 24, 1989 | SESE |
| K842933 | CARBOL-FUCHSIN, ZIEHL-NEEDSEN | E K Ind., Inc. | Sep 11, 1984 | SESE |
| K792483 | STAINS, COUNTERSTAINS & GEN. PURPOSE | Laboratory Products, Inc. | Dec 18, 1979 | SESE |
| K771390 | HISTOCHEMICAL AFB DEMONSTRATION | Harleco | Aug 22, 1977 | SESE |
Top Applicants
- Alpha-Tec Systems, Inc. — 1 clearance
- E K Ind., Inc. — 1 clearance
- Harleco — 1 clearance
- Laboratory Products, Inc. — 1 clearance
