Validate 406re
by LGC Clinical Diagnostics, Inc.
Validate 406re is a Class I device made by LGC Clinical Diagnostics, Inc., cleared under FDA 510(k) K123127 on 14 Jun 2013 and listed in FDA GUDID since 2 Mar 2020 (UDI-DI 00859110005715), 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 | Number00859110005715 | Date2 Mar 2020 | StatusListed |
| United States | FDA 510(k)SESE | NumberK123127 | Date14 Jun 2013 | StatusActive |
Official records
- AccessGUDID record 00859110005715
- FDA 510(k) database K123127
Across registries
- FDA 510(k) K123127 decided 14 Jun 2013 Active
- FDA GUDID UDI-DI 00859110005715 listed 2 Mar 2020 Listed
Timeline
- Cleared FDA 510(k) K123127
- Listed FDA GUDID 00859110005715
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Validate
- Generic name
- Free (unbound) prostate specific antigen (fPSA) IVD, control
- Model / Ref / Catalog
- 406re
- Primary DI / UDI-DI
- 00859110005715
- 510(k) Number
- FDA product code
- JJX
- GMDN term
- Free (unbound) prostate specific antigen (fPSA) IVD, control
- Device class
- Class I
- Regulation number
- 862.1660
- GUDID distribution status
- In Commercial Distribution
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