FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ACRYTOL, MOUNTING MEDIUM
K Number: K810323
·
Decision Mar 6, 1981
Classifications
1
FEI Numbers
3
Registration Numbers
3
Same Product Code
2
Applicant Total
12
Review Days
28
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Basic Information
- Device Name
- ACRYTOL, MOUNTING MEDIUM
- K Number
- K810323
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 864.4010
- Medical Specialty
- Pathology
- Decision
- Substantially Equivalent
- Applicant
- Surgipath
- Date Received
- February 6, 1981
- Decision Date
- March 6, 1981
- Product Code
- KEP
- Advisory Committee
- Pathology
- 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 |
|---|---|---|---|
| KEP | Media, Mounting, Oil Soluble | FDA class 1 | Pathology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KEP), ordered by most recent decision date.
CLEARIUM, MOUNTING MEDIUM
FDA 510(k)
FDA Class 1
·Pathology
ENTELLAN
FDA 510(k)
FDA Class 1
·Pathology
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 |
| K811826 | EOSIN Y | 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 |