Product code HYB
- Device name
- Eosin Y
- 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 |
|---|---|---|---|
| K893663 | INSTANT EOSIN-AQUEOUS | Shandon, Inc. | 1989-06-13 |
| K880596 | EOSIN Y SOLUTION, ALCOHOLIC, WITH PHLOXINE | Sigma Chemical Co. | 1988-03-31 |
| K880240 | INSTANT EOSIN-ALCOHOLIC | Shandon, Inc. | 1988-03-03 |
| K843426 | EOSIN Y 1% ALCOHOLIC | Accra Laboratories, Inc. | 1984-09-27 |
| K822982 | MIDAS 100 HEMACOLOR STAIN #66030 | Emd Chemicals, Inc. | 1982-10-27 |
| K821574 | EOSIN Y SOLUTIN, AGUEOUS | Sigma Chemical Co. | 1982-06-10 |
| K821573 | EOSIN Y SOLUTION ALCHOLIC | Sigma Chemical Co. | 1982-06-09 |
| K811797 | EOSIN-Y | Richard-Allan Medical Ind., Inc. | 1981-07-28 |
| K811826 | EOSIN Y | Surgipath | 1981-07-10 |
| K800942 | VOLU-SOL EOSIN Y STAIN | Volu Sol Medical Industries | 1980-05-08 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10849832015786 | Leica Biosystems | Leica Biosystems Richmond, Inc. | 2024-12-17 |
| 00849832002642 | Leica Biosystems | Leica Biosystems Richmond, Inc. | 2024-12-17 |
| 00849832017981 | Leica Biosystems | Leica Biosystems Richmond, Inc. | 2024-12-17 |
| 00849832015789 | Leica Biosystems | Leica Biosystems Richmond, Inc. | 2024-12-17 |
| 00849832013099 | Leica Biosystems | Leica Biosystems Richmond, Inc. | 2024-12-16 |
| 10849832015779 | Leica Biosystems | Leica Biosystems Richmond, Inc. | 2024-12-16 |
| 00673693087407 | Epredia | RICHARD-ALLAN SCIENTIFIC COMPANY | 2024-09-04 |
| 00673693483209 | Epredia | RICHARD-ALLAN SCIENTIFIC COMPANY | 2024-09-04 |
| 00673693228619 | Epredia | RICHARD-ALLAN SCIENTIFIC COMPANY | 2024-09-04 |
| 00673693228602 | Epredia | RICHARD-ALLAN SCIENTIFIC COMPANY | 2024-09-04 |
| 00673693228596 | Epredia | RICHARD-ALLAN SCIENTIFIC COMPANY | 2024-09-04 |
| 00673693228589 | Epredia | RICHARD-ALLAN SCIENTIFIC COMPANY | 2024-09-04 |
| 00673693228510 | Epredia | RICHARD-ALLAN SCIENTIFIC COMPANY | 2024-09-04 |
| 00673693228503 | Epredia | RICHARD-ALLAN SCIENTIFIC COMPANY | 2024-09-04 |
| 00673693087445 | Epredia | RICHARD-ALLAN SCIENTIFIC COMPANY | 2024-09-04 |
| 00673693087391 | Epredia | RICHARD-ALLAN SCIENTIFIC COMPANY | 2024-09-04 |
| 00673693087384 | Epredia | RICHARD-ALLAN SCIENTIFIC COMPANY | 2024-09-04 |
| 00673693087377 | Epredia | RICHARD-ALLAN SCIENTIFIC COMPANY | 2024-09-04 |
| 00673693087360 | Epredia | RICHARD-ALLAN SCIENTIFIC COMPANY | 2024-09-04 |
| 00673693087346 | Epredia | RICHARD-ALLAN SCIENTIFIC COMPANY | 2024-09-04 |
| 06973471960668 | BioSci™ | Shenzhen Dakewe Bio-engineering Co., Ltd | 2023-09-12 |
| 07290012140891 | QwikCheck Vitality Kit | M.E.S. MEDICAL ELECTRONIC SYSTEMS LTD. | 2023-06-08 |
| 00613647023150 | Fisherbrand | FISHER SCIENTIFIC COMPANY L.L.C. | 2022-12-07 |
| 20613647023154 | Fisherbrand | FISHER SCIENTIFIC COMPANY L.L.C. | 2022-12-07 |
| 00847627014443 | Rubens Eosin-Phloxine | BIOCARE MEDICAL LLC | 2022-12-07 |
| 00847627014436 | Edgar Degas Eosin | BIOCARE MEDICAL LLC | 2022-09-23 |
| 04015630974757 | VENTANA HE 600 Eosin | Ventana Medical Systems, Inc. | 2021-08-31 |
| 07350025610191 | Nidacon | Nidacon International AB | 2017-12-15 |