FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ASPERGILLUS SP., ANTIGEN
K Number: K792687
·
Decision Jan 17, 1980
Classifications
1
FEI Numbers
1
Registration Numbers
1
Same Product Code
2
Applicant Total
92
Review Days
21
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Basic Information
- Device Name
- ASPERGILLUS SP., ANTIGEN
- K Number
- K792687
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3800
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Applicant
- Meridian Diagnostics, Inc.
- Date Received
- December 27, 1979
- Decision Date
- January 17, 1980
- Product Code
- JWI
- Advisory Committee
- Orthopedic
- Review Advisory Committee
- MI
- 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 |
|---|---|---|---|
| JWI | Prosthesis, Wrist, 2 Part Metal-Plastic Articulation, Semi-Constrained | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
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