Eosin Y
FDA product code HYB · Class I (low risk) · 21 CFR 864.1850 · Hematology
10510(k) clearances
0PMA approvals
3recalls
GMP exemptexempt from GMP rules
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K893663 | Instant Eosin-AqueousHYB · Traditional | Shandon, Inc. | 06/13/1989SE |
| K880596 | Eosin Y Solution, Alcoholic, with PhloxineHYB · Traditional | Sigma Chemical Co. | 03/31/1988SE |
| K880240 | Instant Eosin-AlcoholicHYB · Traditional | Shandon, Inc. | 03/03/1988SE |
| K843426 | Eosin Y 1% AlcoholicHYB · Traditional | Accra Laboratories, Inc. | 09/27/1984SE |
| K822982 | Midas 100 Hemacolor Stain #66030HYB · Traditional | Emd Chemicals, Inc. | 10/27/1982SE |
| K821574 | Eosin Y Solutin, AgueousHYB · Traditional | Sigma Chemical Co. | 06/10/1982SE |
| K821573 | Eosin Y Solution AlcholicHYB · Traditional | Sigma Chemical Co. | 06/09/1982SE |
| K811797 | Eosin-YHYB · Traditional | Richard-Allan Medical Ind., Inc. | 07/28/1981SE |
| K811826 | Eosin YHYB · Traditional | Surgipath | 07/10/1981SE |
| K800942 | Volu-Sol Eosin Y StainHYB · Traditional | Volu Sol Medical Industries | 05/08/1980SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1029-2010 | SS-H2O Aerospray Deionized Water, 500 mL, IVD, Wescor, Inc, Logan, Utah 84321.Stains used for diagnostic use may be contaminated with bacteria. | Wescor, Inc | 01/06/2010Terminated |
| Z-1028-2010 | SS-035CG, Hematology Reagent C Eosin Stain, 1 U.S. Gallon, IVD, Wescor, Inc, Logan, Utah…Stains used for diagnostic use may be contaminated with bacteria. | Wescor, Inc | 01/06/2010Terminated |
| Z-1027-2010 | SS-035C, Hematology Reagent C Eosin Stain, 500 mL, IVD, Wescor, Inc, Logan, Utah 84321.…Stains used for diagnostic use may be contaminated with bacteria. | Wescor, Inc | 01/06/2010Terminated |