Liquichek 27103
Liquichek 27103 is a Class II device made by Bio-Rad Laboratories, cleared under FDA 510(k) K032017 on 8 Aug 2003 and listed in FDA GUDID since 12 Sep 2016 (UDI-DI 00847661004509), 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 | Number00847661004509 | Date12 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK032017 | Date8 Aug 2003 | StatusActive |
Official records
- AccessGUDID record 00847661004509
- FDA 510(k) database K032017
Across registries
- FDA 510(k) K032017 decided 8 Aug 2003 Active
- FDA GUDID UDI-DI 00847661004509 listed 12 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K032017
- Listed FDA GUDID 00847661004509
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Liquichek
- Generic name
- D-dimer IVD, control
- Model / Ref / Catalog
- 27103
- Primary DI / UDI-DI
- 00847661004509
- 510(k) Number
- FDA product code
- GGN
- GMDN term
- D-dimer IVD, control
- Device class
- Class II
- Regulation number
- 864.5425
- GUDID distribution status
- In Commercial Distribution
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