510(k) K792687
K792687 is an FDA 510(k) premarket notification submitted by Meridian Diagnostics, Inc. for the device "ASPERGILLUS SP., ANTIGEN". The FDA issued a decision of Substantially Equivalent on January 17, 1980. The device falls under product code JWI (Prosthesis, Wrist, 2 Part Metal-Plastic Articulation, Semi-Constrained), a Class II device regulated under 21 CFR 888.3800. Meridian Diagnostics, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 17, 1980
- Date Received
- December 27, 1979
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Prosthesis, Wrist, 2 Part Metal-Plastic Articulation, Semi-Constrained
- Device Class
- Class II
- Regulation Number
- 888.3800
- Review Panel
- OR
- Submission Type