Product code HZJ
- Device name
- Stain, Papanicolau
- Medical specialty
- Hematology
- Device class
- 1
- Regulation number
- 864.1850
- Review panel
- PA
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- Y
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K843427 | GILL PAPANICOLAOU STAIN EA-1 & 2 OG-6 | Accra Laboratories, Inc. | 1984-10-02 |
| K842735 | PAP STAIN EA-65 | E K Ind., Inc. | 1984-09-11 |
| K842739 | PAP STAIN, EA-36 | E K Ind., Inc. | 1984-09-11 |
| K842736 | PAP STAIN, OG-6 | E K Ind., Inc. | 1984-08-17 |
| K842738 | PAP STAIN EA-50 | E K Ind., Inc. | 1984-08-17 |
| K840054 | PAPANICOLAOU STAIN SYS HT40 | Sigma Chemical Co. | 1984-02-17 |
| K822035 | VOLU-SOL GILLS EA | Volu Sol Medical Industries | 1982-08-03 |
| K820027 | MODIFIED EA 50 | Surgipath | 1982-02-04 |
| K812086 | EA 65 | Surgipath | 1981-08-13 |
| K812087 | EA 50 | Surgipath | 1981-08-13 |
| K800322 | VOLU-SOL EA-50 STAIN | Volu Sol Medical Industries | 1980-02-26 |
| K800325 | VOLU-SOL HISTO./CYTO. STAIN MOD. #EA65 | Volu Sol Medical Industries | 1980-02-26 |
| K781582 | PAPANICOLAOU STAIN EA-36 | Bioscientific | 1978-10-10 |
| K781583 | PAPANICOLAOU STAIN :EA-50: | Bioscientific | 1978-10-10 |
| K781588 | PAPANICOLAOU STIAN OG-6 | Bioscientific | 1978-10-10 |
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|---|---|---|---|
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| 00673693088312 | Epredia | RICHARD-ALLAN SCIENTIFIC COMPANY | 2024-08-09 |
| 00673693228572 | Epredia | RICHARD-ALLAN SCIENTIFIC COMPANY | 2024-08-09 |
| 00673693228565 | Epredia | RICHARD-ALLAN SCIENTIFIC COMPANY | 2024-08-09 |
| 00673693228558 | Epredia | RICHARD-ALLAN SCIENTIFIC COMPANY | 2024-08-09 |
| 00673693228541 | Epredia | RICHARD-ALLAN SCIENTIFIC COMPANY | 2024-08-09 |
| 00673693228534 | Epredia | RICHARD-ALLAN SCIENTIFIC COMPANY | 2024-08-09 |
| 00673693088404 | Epredia | RICHARD-ALLAN SCIENTIFIC COMPANY | 2024-08-09 |
| 00673693088381 | Epredia | RICHARD-ALLAN SCIENTIFIC COMPANY | 2024-08-09 |
| 00673693088374 | Epredia | RICHARD-ALLAN SCIENTIFIC COMPANY | 2024-08-09 |
| 00673693088367 | Epredia | RICHARD-ALLAN SCIENTIFIC COMPANY | 2024-08-09 |
| 00673693088343 | Epredia | RICHARD-ALLAN SCIENTIFIC COMPANY | 2024-08-09 |
| 00673693088329 | Epredia | RICHARD-ALLAN SCIENTIFIC COMPANY | 2024-08-09 |
| 00673693088305 | Epredia | RICHARD-ALLAN SCIENTIFIC COMPANY | 2024-08-09 |
| 00673693088299 | Epredia | RICHARD-ALLAN SCIENTIFIC COMPANY | 2024-08-09 |
| 00673693088282 | Epredia | RICHARD-ALLAN SCIENTIFIC COMPANY | 2024-08-09 |
| 00673693088275 | Epredia | RICHARD-ALLAN SCIENTIFIC COMPANY | 2024-08-09 |
| 00673693088268 | Epredia | RICHARD-ALLAN SCIENTIFIC COMPANY | 2024-08-09 |
| 00673693088251 | Epredia | RICHARD-ALLAN SCIENTIFIC COMPANY | 2024-08-09 |
| 00673693088244 | Epredia | RICHARD-ALLAN SCIENTIFIC COMPANY | 2024-08-09 |
| 00673693088213 | Epredia | RICHARD-ALLAN SCIENTIFIC COMPANY | 2024-08-09 |
| 00673693088206 | Epredia | RICHARD-ALLAN SCIENTIFIC COMPANY | 2024-08-09 |
| 00613647023167 | Fisherbrand | FISHER SCIENTIFIC COMPANY L.L.C. | 2022-12-07 |
| 20613647023161 | Fisherbrand | FISHER SCIENTIFIC COMPANY L.L.C. | 2022-12-07 |
| SO942852042008 | Rowley Biochemical Harris Hematoxylin | TRANSENE COMPANY, INC. | 2019-09-13 |
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| M8003852042008 | Rowley Biochemical Orange G | TRANSENE COMPANY, INC. | 2019-09-13 |
| M8015852042008 | Rowley Biochemical Modified Orange G | TRANSENE COMPANY, INC. | 2019-09-13 |
| SO323852042008 | Rowley Biochemical EA Counterstain | TRANSENE COMPANY, INC. | 2019-09-13 |
| SO430852042008 | Rowley Biochemical Scott's Water | TRANSENE COMPANY, INC. | 2019-09-13 |