FDA Product Code
FDA Product Code HZJ — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Hematology
- 21 CFR Citation
- 864.1850
510(k) Clearances — 15 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K843427 | GILL PAPANICOLAOU STAIN EA-1 & 2 OG-6 | Accra Laboratories, Inc. | 1984-10-02 | Traditional | PDF ↗ |
| K842735 | PAP STAIN EA-65 | E K Ind., Inc. | 1984-09-11 | Traditional | PDF ↗ |
| K842739 | PAP STAIN, EA-36 | E K Ind., Inc. | 1984-09-11 | Traditional | PDF ↗ |
| K842738 | PAP STAIN EA-50 | E K Ind., Inc. | 1984-08-17 | Traditional | PDF ↗ |
| K842736 | PAP STAIN, OG-6 | E K Ind., Inc. | 1984-08-17 | Traditional | PDF ↗ |
| K840054 | PAPANICOLAOU STAIN SYS HT40 | Sigma Chemical Co. | 1984-02-17 | Traditional | PDF ↗ |
| K822035 | VOLU-SOL GILLS EA | Volu Sol Medical Industries | 1982-08-03 | Traditional | PDF ↗ |
| K820027 | MODIFIED EA 50 | Surgipath | 1982-02-04 | Traditional | PDF ↗ |
| K812087 | EA 50 | Surgipath | 1981-08-13 | Traditional | PDF ↗ |
| K812086 | EA 65 | Surgipath | 1981-08-13 | Traditional | PDF ↗ |
| K800322 | VOLU-SOL EA-50 STAIN | Volu Sol Medical Industries | 1980-02-26 | Traditional | PDF ↗ |
| K800325 | VOLU-SOL HISTO./CYTO. STAIN MOD. #EA65 | Volu Sol Medical Industries | 1980-02-26 | Traditional | PDF ↗ |
| K781582 | PAPANICOLAOU STAIN EA-36 | Bioscientific | 1978-10-10 | Traditional | PDF ↗ |
| K781588 | PAPANICOLAOU STIAN OG-6 | Bioscientific | 1978-10-10 | Traditional | PDF ↗ |
| K781583 | PAPANICOLAOU STAIN :EA-50: | Bioscientific | 1978-10-10 | Traditional | PDF ↗ |
Product code HZJ · Class I · Hematology. Data: openFDA.