FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
TISSUE EMBEDDING MEDIUM
K Number: K893772
·
Decision Jun 22, 1989
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
10
Applicant Total
4
Review Days
31
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Basic Information
- Device Name
- TISSUE EMBEDDING MEDIUM
- K Number
- K893772
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 864.4010
- Medical Specialty
- Pathology
- Decision
- Substantially Equivalent
- Applicant
- Stephens Scientific
- Date Received
- May 22, 1989
- Decision Date
- June 22, 1989
- Product Code
- KEO
- 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 |
|---|---|---|---|
| KEO | Formulations, Paraffin, All | FDA class 1 | Pathology |
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