FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
FORMALIN BUFFER CONCENTRATE
K Number: K771201
·
Decision Aug 22, 1977
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
6
Applicant Total
3
Review Days
48
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Basic Information
- Device Name
- FORMALIN BUFFER CONCENTRATE
- K Number
- K771201
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 864.4010
- Medical Specialty
- Pathology
- Decision
- Substantially Equivalent
- Applicant
- Central Labs. Assoc. MD Pathologists
- Date Received
- July 5, 1977
- Decision Date
- August 22, 1977
- Product Code
- IGG
- 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 |
|---|---|---|---|
| IGG | Formaldehyde (Formalin, Formol) | FDA class 1 | Pathology |
Similar 510(k) Clearances
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