Product code HZJ— Hematology
EA 50
- Classification name
- Stain, Papanicolau
- Device class
- Class 1
- Regulation
- 21 CFR 864.1850
- Advisory panel
- Hematology
- Total cleared
- 15
- First cleared
- Most recent
Market context for product code HZJ
FDA has cleared devices under product code HZJ between 1978 and 1984, filed by 6 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.
Clearances per year
- 1984
- 1982
- 1981
- 1980
- 1978
Top applicants under product code HZJ
Recent clearances under product code HZJ
- K843427 — GILL PAPANICOLAOU STAIN EA-1 & 2 OG-6
- K842735 — PAP STAIN EA-65
- K842739 — PAP STAIN, EA-36
- K842736 — PAP STAIN, OG-6
- K842738 — PAP STAIN EA-50
- K840054 — PAPANICOLAOU STAIN SYS HT40
- K822035 — VOLU-SOL GILLS EA
- K820027 — MODIFIED EA 50
- K812086 — EA 65
- K812087 — EA 50
- K800322 — VOLU-SOL EA-50 STAIN
- K800325 — VOLU-SOL HISTO./CYTO. STAIN MOD. #EA65
- K781582 — PAPANICOLAOU STAIN EA-36
- K781583 — PAPANICOLAOU STAIN :EA-50:
- K781588 — PAPANICOLAOU STIAN OG-6
Data sourced from openFDA. This site is unofficial and independent of the FDA.