ISE Cleaning Solution Kit 5421
by Medica Corp.
ISE Cleaning Solution Kit 5421 is a Class II device made by Medica Corp., cleared under FDA 510(k) K000926 on 15 May 2000 and listed in FDA GUDID since 11 Dec 2018 (UDI-DI 00386100002794), active as of 23 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 | Number00386100002794 | Date11 Dec 2018 | StatusListed |
| United States | FDA 510(k)SESE | NumberK000926 | Date15 May 2000 | StatusActive |
Official records
- AccessGUDID record 00386100002794
- FDA 510(k) database K000926
Across registries
- FDA 510(k) K000926 decided 15 May 2000 Active
- FDA GUDID UDI-DI 00386100002794 listed 11 Dec 2018 Listed
Timeline
- Cleared FDA 510(k) K000926
- Listed FDA GUDID 00386100002794
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- ISE Cleaning Solution Kit
- Generic name
- Wash/cleaning solution IVD, automated/semi-automated system
- Model / Ref / Catalog
- 5421
- Primary DI / UDI-DI
- 00386100002794
- 510(k) Number
- FDA product code
- JGS, CEM, CGZ
- GMDN term
- Wash/cleaning solution IVD, automated/semi-automated system
- Device class
- Class II
- Regulation number
- 862.1665, 862.1600, 862.1170
- GUDID distribution status
- In Commercial Distribution
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