LED · Stains, Chemical Solution
Hematology · 21 CFR 864.1850 · Class 1
Overview
| Product Code | LED |
|---|---|
| Device Name | Stains, Chemical Solution |
| 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 (16 of 16)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K051409 | SLIVASURE | Scandinavian Formulas, Inc. | Aug 8, 2005 | SESE |
| K023046 | SST SALIVA SUPPORTING TABLETS | Sinclair Pharmaceuticals, Ltd. | Dec 2, 2002 | SESE |
| K860795 | SPOTTEST CALCOFLUOR WHITE REAGENT | Difco Laboratories, Inc. | Mar 12, 1986 | SESE |
| K860321 | LYSOCOLOR | Cytocolor, Inc. | Feb 20, 1986 | SESE |
| K860320 | GRANULOCOLOR | Cytocolor, Inc. | Feb 20, 1986 | SESE |
| K860319 | MEGACOLOR | Cytocolor, Inc. | Feb 20, 1986 | SESE |
| K860317 | NEUTROCOLOR | Cytocolor, Inc. | Feb 20, 1986 | SESE |
| K860316 | PANOPTIKON | Cytocolor, Inc. | Feb 20, 1986 | SESE |
| K854176 | POLYCHROME IV STAIN | Devetec, Inc. | Oct 31, 1985 | SESE |
| K851481 | SPOTTEST IODINE SOLUTION DOBELL & O'CONNOR | Difco Laboratories, Inc. | Apr 29, 1985 | SESE |
| K842930 | GOMORI'S TRICHROME STAIN | E K Ind., Inc. | Sep 11, 1984 | SESE |
| K842727 | SUPERMOUNT | E K Ind., Inc. | Aug 3, 1984 | SESE |
| K840087 | PRESERV GOMORI TRICHROME STAIN 125/500 | Preventive Diagnostics Corp. | Feb 10, 1984 | SESE |
| K833388 | IRON STAIN PROCEDURE HT20 | Sigma Chemical Co. | Oct 31, 1983 | SESE |
| K833167 | TRICHROME STAIN LG SOLUTION | Sigma Chemical Co. | Oct 31, 1983 | SESE |
| K812192 | LACTO-PHENOL ANILINE BLUE MOUNTING FLUID | American Scientific Products | Aug 31, 1981 | SESE |
Top Applicants
- Cytocolor, Inc. — 5 clearances
- Sigma Chemical Co. — 2 clearances
- E K Ind., Inc. — 2 clearances
- Difco Laboratories, Inc. — 2 clearances
- Sinclair Pharmaceuticals, Ltd. — 1 clearance
