Retic-Chex Linearity BC 285535
by Streck
Retic-Chex Linearity BC 285535 is a Class II device made by Streck, cleared under FDA 510(k) K070199 on 23 Feb 2007 and listed in FDA GUDID since 19 Sep 2016 (UDI-DI 00844509001133), 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 | Number00844509001133 | Date19 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK070199 | Date23 Feb 2007 | StatusActive |
Official records
- AccessGUDID record 00844509001133
- FDA 510(k) database K070199
Across registries
- FDA 510(k) K070199 decided 23 Feb 2007 Active
- FDA GUDID UDI-DI 00844509001133 listed 19 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K070199
- Listed FDA GUDID 00844509001133
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Retic-Chex Linearity BC
- Generic name
- Reticulocyte count IVD, control
- Model / Ref / Catalog
- 285535
- Primary DI / UDI-DI
- 00844509001133
- 510(k) Number
- FDA product code
- JPK
- GMDN term
- Reticulocyte count IVD, control
- Device class
- Class II
- Regulation number
- 864.8625
- GUDID distribution status
- In Commercial Distribution
- Size
- Total Volume — 3.0 Milliliter
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