HZJ — Stain, Papanicolau Class I
FDA product code HZJ covers "Stain, Papanicolau", a Class I medical device regulated under 21 CFR 864.1850. Submissions are reviewed by the Hematology panel. At least 15 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- HZJ
- Device Class
- Class I
- Regulation Number
- 864.1850
- Submission Type
- Review Panel
- PA
- Medical Specialty
- Hematology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K843427 | accra laboratories | GILL PAPANICOLAOU STAIN EA-1 & 2 OG-6 | October 2, 1984 |
| K842735 | e k ind | PAP STAIN EA-65 | September 11, 1984 |
| K842739 | e k ind | PAP STAIN, EA-36 | September 11, 1984 |
| K842738 | e k ind | PAP STAIN EA-50 | August 17, 1984 |
| K842736 | e k ind | PAP STAIN, OG-6 | August 17, 1984 |
| K840054 | sigma chemical | PAPANICOLAOU STAIN SYS HT40 | February 17, 1984 |
| K822035 | volu sol medical industries | VOLU-SOL GILLS EA | August 3, 1982 |
| K820027 | surgipath | MODIFIED EA 50 | February 4, 1982 |
| K812086 | surgipath | EA 65 | August 13, 1981 |
| K812087 | surgipath | EA 50 | August 13, 1981 |
| K800322 | volu sol medical industries | VOLU-SOL EA-50 STAIN | February 26, 1980 |
| K800325 | volu sol medical industries | VOLU-SOL HISTO./CYTO. STAIN MOD. #EA65 | February 26, 1980 |
| K781588 | bioscientific | PAPANICOLAOU STIAN OG-6 | October 10, 1978 |
| K781582 | bioscientific | PAPANICOLAOU STAIN EA-36 | October 10, 1978 |
| K781583 | bioscientific | PAPANICOLAOU STAIN :EA-50: | October 10, 1978 |