Sickle-Chex 217653
by Streck
Sickle-Chex 217653 is a Class II device made by Streck, cleared under FDA 510(k) K013316 on 6 Nov 2001 and listed in FDA GUDID since 19 Sep 2016 (UDI-DI 00844509000884), 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 | Number00844509000884 | Date19 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK013316 | Date6 Nov 2001 | StatusActive |
Official records
- AccessGUDID record 00844509000884
- FDA 510(k) database K013316
Across registries
- FDA 510(k) K013316 decided 6 Nov 2001 Active
- FDA GUDID UDI-DI 00844509000884 listed 19 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K013316
- Listed FDA GUDID 00844509000884
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Sickle-Chex
- Generic name
- Haemoglobin S (HbS) IVD, control
- Model / Ref / Catalog
- 217653
- Primary DI / UDI-DI
- 00844509000884
- 510(k) Number
- FDA product code
- GHM
- GMDN term
- Haemoglobin S (HbS) IVD, control
- Device class
- Class II
- Regulation number
- 864.7825
- GUDID distribution status
- In Commercial Distribution
- Size
- Total Volume — 2.5 Milliliter
Similar devices
Other devices filed under FDA product code GHM (Test, Sickle Cell).
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- SICKLE CELL REAGENT SET by MICHCLONE ASSOCIATES, INC.
- Sickle-Chex Solubility Kit by Streck Laboratories, Inc.
- SICKLE-STAT HEMOGLOBIN S SCREEN KIT by Clinical Technology Corp.
- SICKLE-CHECK by Panmed, Inc.
- HEMOCARD-AS by Isolab, Inc.
- THROMBO SCREEN SICKLE CELL ASSAY SET by Pacific Hemostasis
- MONOJECT SICKLE CELL KIT by Sherwood Medical Co.