MeDiCa 0401-M
MeDiCa 0401-M is a Class II device made by Scimedx Corp., cleared under FDA 510(k) K790430 on 23 Apr 1979 and listed in FDA GUDID since 1 Dec 2020 (UDI-DI 00813545026660), 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 | Number00813545026660 | Date1 Dec 2020 | StatusListed |
| United States | FDA 510(k)SESE | NumberK790430 | Date23 Apr 1979 | StatusActive |
Official records
- AccessGUDID record 00813545026660
- FDA 510(k) database K790430
Across registries
- FDA 510(k) K790430 decided 23 Apr 1979 Active
- FDA GUDID UDI-DI 00813545026660 listed 1 Dec 2020 Listed
Timeline
- Cleared FDA 510(k) K790430
- Listed FDA GUDID 00813545026660
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- Withdrawn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
- 0401-M
- Primary DI / UDI-DI
- 00813545026660
- 510(k) Number
- FDA product code
- DBE
- GMDN term
- Smooth muscle antibody IVD, kit, fluorescent immunoassay
- Device class
- Class II
- Regulation number
- 866.5120
- GUDID distribution status
- In Commercial Distribution
Similar devices
Other devices filed under FDA product code DBE (Antismooth Muscle Antibody, Indirect Immunofluorescent, Antigen, Control).
- ANTI-MITOCHONDRIAL by Meloy Laboratories, Inc.
- AFT TM SYSTEM ANTISMOOTH MUSCLE ANTIBODY by Calbiochem-Behring Corp.
- IMMUNOP. ANTISMOOTH MUSCLE ANTIBODY KIT by Clinical Sciences, Inc.
- ANTISMOOTH MUSCLE ANTIBODY TEST SYS by Immuno-Products Industries
- TEST, (IVDP) SMOOTHMUSCLE ANTIBODY by ZEUS SCIENTIFIC, INC.
- MEDICA II-F-ASMA TEST KIT by Medica Corp.