Clinical Laboratory Analyzing System
510(k) K041230
Clinical Laboratory Analyzing System is a Class II device made by Hemocue, Inc., cleared under FDA 510(k) K041230 on 20 May 2004, active as of 11 Oct 2026.
Active
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK041230 | Date20 May 2004 | StatusActive |
Official records
- FDA 510(k) database K041230
Recalls
-
- Terminated Z-1848-2011
Incorrect configurations settings in software. As a result, certain error codes do not trigger appropriately. These error codes are: E01, E02 and E05 which are all related to the optronic performance of the analyzer. Possible incorrect results.
Timeline
- Cleared FDA 510(k) K041230
- Recall initiated FDA recalls Z-1848-2011
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- LFR
- Device class
- Class II
- Regulation
- 21 CFR Part 862.1345
- Advisory committee
- Clinical Chemistry
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K041230
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| HemoCue® Glucose 201 DM Analyzer 121422 | 121422 / 121422 | 07311091214225 | — | On the market |
| HemoCue® Glucose 201 DM Analyzer 121444 | 121444 / 121444 | 07311091214447 | — | On the market |
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