Cordia Tg
by Cordis Corp.
510(k) K821489
Cordia Tg is a Class II device made by Cordis Corp., cleared under FDA 510(k) K821489 on 9 Jun 1982, active as of 11 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK821489 | Date9 Jun 1982 | StatusActive |
Official records
- FDA 510(k) database K821489
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- JZO
- Device class
- Class II
- Regulation
- 21 CFR Part 866.5870
- Advisory committee
- Immunology
- FDA decision
- SESE Substantially Equivalent
Similar devices
Other devices filed under FDA product code JZO (System, Test, Thyroid Autoantibody).
- I-125 ANTI-THYROGLOBULIN ANTIBODY IRMA TEST KIT by Cronus
- ANTI-TPO EIA DIAGNOSTIC TEST KIT by The Binding Site, Ltd.
- MODIFIED KRONUS TEST KIT FOR ANTIBODIES TO (TPO) by KRONUS, INC.
- AUTOSTAT ANTI-THYROID MICROSOMAL KIT by Cogent Diagnotics, Ltd.
- DIASTAT ANTI-THYROGLOBULIN KIT by Shield Diagnostics, Ltd.
- IMMULITE ANTI-TG AB by Diagnostic Products Corp.
- Thyretain 40-25000.V2 by DIAGNOSTIC HYBRIDS, INC.
- DIASTAT ANTI-THYROID PEROXIDASE ELISA MODEL #300 by Axis-Shield Diagnostics Limited
- Elecsys Anti-Tg by Roche Diagnostics Corp.
- ARCHITECT 2K46-20 02K4620 by Abbott Ireland Diagnostics