HZJ · Stain, Papanicolau
Hematology · 21 CFR 864.1850 · Class 1
Overview
| Product Code | HZJ |
|---|---|
| Device Name | Stain, Papanicolau |
| 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 (15 of 15)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K843427 | GILL PAPANICOLAOU STAIN EA-1 & 2 OG-6 | Accra Laboratories, Inc. | Oct 2, 1984 | SESE |
| K842739 | PAP STAIN, EA-36 | E K Ind., Inc. | Sep 11, 1984 | SESE |
| K842735 | PAP STAIN EA-65 | E K Ind., Inc. | Sep 11, 1984 | SESE |
| K842738 | PAP STAIN EA-50 | E K Ind., Inc. | Aug 17, 1984 | SESE |
| K842736 | PAP STAIN, OG-6 | E K Ind., Inc. | Aug 17, 1984 | SESE |
| K840054 | PAPANICOLAOU STAIN SYS HT40 | Sigma Chemical Co. | Feb 17, 1984 | SESE |
| K822035 | VOLU-SOL GILLS EA | Volu Sol Medical Industries | Aug 3, 1982 | SESE |
| K820027 | MODIFIED EA 50 | Surgipath | Feb 4, 1982 | SESE |
| K812087 | EA 50 | Surgipath | Aug 13, 1981 | SESE |
| K812086 | EA 65 | Surgipath | Aug 13, 1981 | SESE |
| K800325 | VOLU-SOL HISTO./CYTO. STAIN MOD. #EA65 | Volu Sol Medical Industries | Feb 26, 1980 | SESE |
| K800322 | VOLU-SOL EA-50 STAIN | Volu Sol Medical Industries | Feb 26, 1980 | SESE |
| K781588 | PAPANICOLAOU STIAN OG-6 | Bioscientific | Oct 10, 1978 | SESE |
| K781583 | PAPANICOLAOU STAIN :EA-50: | Bioscientific | Oct 10, 1978 | SESE |
| K781582 | PAPANICOLAOU STAIN EA-36 | Bioscientific | Oct 10, 1978 | SESE |
Top Applicants
- E K Ind., Inc. — 4 clearances
- Bioscientific — 3 clearances
- Surgipath — 3 clearances
- Volu Sol Medical Industries — 3 clearances
- Accra Laboratories, Inc. — 1 clearance
