HZJ
15 FDA 510(k) clearances · Product code
22 daysmedian time to decision
60 days90th percentile
15clearances measured
FDA profile
- Official device name
- Stain, Papanicolau
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 864.1850
- Medical specialty
- Hematology
- Flags
- GMP exempt
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| GILL PAPANICOLAOU STAIN EA-1 & 2 OG-6 (K843427) | Accra Laboratories, Inc. | 1984-10-02 |
| PAP STAIN EA-65 (K842735) | E K Ind., Inc. | 1984-09-11 |
| PAP STAIN, EA-36 (K842739) | E K Ind., Inc. | 1984-09-11 |
| PAP STAIN EA-50 (K842738) | E K Ind., Inc. | 1984-08-17 |
| PAP STAIN, OG-6 (K842736) | E K Ind., Inc. | 1984-08-17 |
| PAPANICOLAOU STAIN SYS HT40 (K840054) | Sigma Chemical Co. | 1984-02-17 |
| VOLU-SOL GILLS EA (K822035) | Volu Sol Medical Industries | 1982-08-03 |
| MODIFIED EA 50 (K820027) | Surgipath | 1982-02-04 |
| EA 65 (K812086) | Surgipath | 1981-08-13 |
| EA 50 (K812087) | Surgipath | 1981-08-13 |
| VOLU-SOL HISTO./CYTO. STAIN MOD. #EA65 (K800325) | Volu Sol Medical Industries | 1980-02-26 |
| VOLU-SOL EA-50 STAIN (K800322) | Volu Sol Medical Industries | 1980-02-26 |
| PAPANICOLAOU STAIN EA-36 (K781582) | Bioscientific | 1978-10-10 |
| PAPANICOLAOU STIAN OG-6 (K781588) | Bioscientific | 1978-10-10 |
| PAPANICOLAOU STAIN :EA-50: (K781583) | Bioscientific | 1978-10-10 |
Track HZJ automatically
Every clearance here is in the API, with alerts when new ones post.