ASPERGILLUS SP., ANTIGEN
FDA 510(k) clearance K792687 · decided 1980-01-17
Clearance details
- K-number
- K792687
- Device name
- ASPERGILLUS SP., ANTIGEN
- Applicant
- Meridian Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1979-12-27
- Decision date
- 1980-01-17
- Days to decision
- 21 days
- Clearance type
- Traditional
- Product code
- JWI
- Device class
- 2
- Regulation number
- 888.3800
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| FIXANO TOTAL TRAPEZIO METACARPAL PROSTHESIS, 2ND (K931265) | Ferguson Medical | 1995-05-22 |
| UNIVERSAL WRIST (K940297) | Turnkey Intergration USA, Inc. | 1995-02-06 |
Recalls involving this device
No recalls on record reference this clearance.