Cholesterol Reference Kit 9557
by Verichem Laboratories, Inc.
Cholesterol Reference Kit 9557 is a Class II device made by Verichem Laboratories, Inc., cleared under FDA 510(k) K924904 on 13 Jan 1993 and listed in FDA GUDID since 17 Jan 2018 (UDI-DI 00852553007230), active as of 22 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 | Number00852553007230 | Date17 Jan 2018 | StatusListed |
| United States | FDA 510(k)SESE | NumberK924904 | Date13 Jan 1993 | StatusActive |
Official records
- AccessGUDID record 00852553007230
- FDA 510(k) database K924904
Across registries
- FDA 510(k) K924904 decided 13 Jan 1993 Active
- FDA GUDID UDI-DI 00852553007230 listed 17 Jan 2018 Listed
Timeline
- Cleared FDA 510(k) K924904
- Listed FDA GUDID 00852553007230
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Cholesterol Reference Kit
- Generic name
- Total cholesterol lipid IVD, calibrator
- Model / reference
- 9557
- Primary DI / UDI-DI
- 00852553007230
- 510(k) Number
- FDA product code
- JIS
- GMDN term
- Total cholesterol lipid IVD, calibrator
- Device class
- Class II
- Regulation number
- 862.1150
- GUDID distribution status
- In Commercial Distribution
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