MeDiCa 8031-200
MeDiCa 8031-200 is a Class II device made by Scimedx Corp., cleared under FDA 510(k) K831100 on 4 May 1983 and listed in FDA GUDID since 1 Dec 2020 (UDI-DI 00813545027391), active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00813545027391 | Date1 Dec 2020 | StatusListed |
| United States | FDA 510(k)SESE | NumberK831100 | Date4 May 1983 | StatusActive |
Official records
- AccessGUDID record 00813545027391
- FDA 510(k) database K831100
Across registries
- FDA 510(k) K831100 decided 4 May 1983 Active
- FDA GUDID UDI-DI 00813545027391 listed 1 Dec 2020 Listed
Timeline
- Cleared FDA 510(k) K831100
- Listed FDA GUDID 00813545027391
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- MeDiCa
- Generic name
- Smooth muscle antibody IVD, kit, fluorescent immunoassay
- Model / Ref / Catalog
- 8031-200
- Primary DI / UDI-DI
- 00813545027391
- 510(k) Number
- FDA product code
- DBL
- GMDN term
- Smooth muscle antibody IVD, kit, fluorescent immunoassay
- Device class
- Class II
- Regulation number
- 866.5660
- GUDID distribution status
- In Commercial Distribution
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