FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
EOSIN Y
K Number: K811826
·
Decision Jul 10, 1981
Classifications
1
FEI Numbers
37
Registration Numbers
37
Same Product Code
9
Applicant Total
12
Review Days
11
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Basic Information
- Device Name
- EOSIN Y
- K Number
- K811826
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 864.1850
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Surgipath
- Date Received
- June 29, 1981
- Decision Date
- July 10, 1981
- Product Code
- HYB
- Advisory Committee
- Hematology
- Review Advisory Committee
- PA
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| HYB | Eosin Y | FDA class 1 | Hematology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HYB), ordered by most recent decision date.
INSTANT EOSIN-AQUEOUS
FDA 510(k)
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·Hematology
EOSIN Y SOLUTION, ALCOHOLIC, WITH PHLOXINE
FDA 510(k)
FDA Class 1
·Hematology
INSTANT EOSIN-ALCOHOLIC
FDA 510(k)
FDA Class 1
·Hematology
EOSIN Y 1% ALCOHOLIC
FDA 510(k)
FDA Class 1
·Hematology
MIDAS 100 HEMACOLOR STAIN #66030
FDA 510(k)
FDA Class 1
·Hematology
EOSIN Y SOLUTIN, AGUEOUS
FDA 510(k)
FDA Class 1
·Hematology
Other Clearances by Surgipath
| K Number | Device Name | ||
|---|---|---|---|
| K820027 | MODIFIED EA 50 | Feb 4, 1982 | Substantially Equivalent |
| K812940 | 10% NEUTRAL BUFFERED FORMALIN CONCENT | Dec 10, 1981 | Substantially Equivalent |
| K812087 | EA 50 | Aug 13, 1981 | Substantially Equivalent |
| K812086 | EA 65 | Aug 13, 1981 | Substantially Equivalent |
| K811825 | ORANGE G-6 | Jul 10, 1981 | Substantially Equivalent |
| K810836 | DECALCIFIER II | Apr 23, 1981 | Substantially Equivalent |
| K810758 | GILL'S HEMATOXYLIN #1 | Apr 14, 1981 | Substantially Equivalent |
| K810733 | HARRIS HEMATOXYLIN | Apr 14, 1981 | Substantially Equivalent |
| K810759 | GILL'S HEMATOXYLIN #2 | Apr 14, 1981 | Substantially Equivalent |
| K810760 | GILL'S HEMATOXYLIN #3 | Apr 14, 1981 | Substantially Equivalent |