FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
LYSING AGENT AF
K Number: K761183
·
Decision Jan 17, 1977
Classifications
1
FEI Numbers
31
Registration Numbers
31
Same Product Code
6
Applicant Total
3
Review Days
46
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Basic Information
- Device Name
- LYSING AGENT AF
- K Number
- K761183
- 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
- December 2, 1976
- Decision Date
- January 17, 1977
- Product Code
- JCE
- 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 |
|---|---|---|---|
| JCE | Solution, Isotonic | FDA class 1 | Pathology |
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