EOSIN Y
FDA 510(k) clearance K811826 · decided 1981-07-10
Clearance details
- K-number
- K811826
- Device name
- EOSIN Y
- Applicant
- Surgipath
- Decision
- Substantially Equivalent
- Date received
- 1981-06-29
- Decision date
- 1981-07-10
- Days to decision
- 11 days
- Clearance type
- Traditional
- Product code
- HYB
- Device class
- 1
- Regulation number
- 864.1850
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| INSTANT EOSIN-AQUEOUS (K893663) | Shandon, Inc. | 1989-06-13 |
| EOSIN Y SOLUTION, ALCOHOLIC, WITH PHLOXINE (K880596) | Sigma Chemical Co. | 1988-03-31 |
| INSTANT EOSIN-ALCOHOLIC (K880240) | Shandon, Inc. | 1988-03-03 |
| EOSIN Y 1% ALCOHOLIC (K843426) | Accra Laboratories, Inc. | 1984-09-27 |
| MIDAS 100 HEMACOLOR STAIN #66030 (K822982) | Emd Chemicals, Inc. | 1982-10-27 |
| EOSIN Y SOLUTIN, AGUEOUS (K821574) | Sigma Chemical Co. | 1982-06-10 |
| EOSIN Y SOLUTION ALCHOLIC (K821573) | Sigma Chemical Co. | 1982-06-09 |
| EOSIN-Y (K811797) | Richard-Allan Medical Ind., Inc. | 1981-07-28 |
| VOLU-SOL EOSIN Y STAIN (K800942) | Volu Sol Medical Industries | 1980-05-08 |
Recalls involving this device
No recalls on record reference this clearance.