HQ-Chex 232758
by Streck
HQ-Chex 232758 is a Class I device made by Streck, cleared under FDA 510(k) K933844 on 27 Dec 1993 and listed in FDA GUDID since 19 Sep 2016 (UDI-DI 00844509001737), 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 | Number00844509001737 | Date19 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK933844 | Date27 Dec 1993 | StatusActive |
Official records
- AccessGUDID record 00844509001737
- FDA 510(k) database K933844
Across registries
- FDA 510(k) K933844 decided 27 Dec 1993 Active
- FDA GUDID UDI-DI 00844509001737 listed 19 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K933844
- Listed FDA GUDID 00844509001737
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- HQ-Chex
- Generic name
- Glucose/haemoglobin (Hb) IVD, control
- Model / Ref / Catalog
- 232758
- Description
- A whole blood glucose and hemoglobin control designed to evaluate the accuracy and precision of HemoCue® analyzers. Contains 1 vial each of level 2 & 3.
- Primary DI / UDI-DI
- 00844509001737
- 510(k) Number
- FDA product code
- JJY
- GMDN term
- Glucose/haemoglobin (Hb) IVD, control
- Device class
- Class I
- Regulation number
- 862.1660
- GUDID distribution status
- In Commercial Distribution
- Size
- Total Volume — 2.5 Milliliter
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