Multi-Lipid Calibrator
by Wako Chemicals USA, Inc. 510(k)
Active
510(k) K042550
Overview
The Multi-Lipid Calibrator is a clinical chemistry device classified as a multi-analyte mixture intended for use in clinical laboratories. It is designed to calibrate analytical instruments for the measurement of cholesterol, HDL, LDL, and triglyceride levels in patient samples.
The device is supplied as a single-use calibrator and is not reusable. It is manufactured by Wako Chemicals USA, Inc. and is intended for use with specific HDL-C and LDL-C reagents. The device is not sterile and does not require storage under specific conditions beyond standard laboratory practices. It is regulated under FDA 510(k) clearance and is associated with the Clinical Chemistry specialty.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK042550 | Date8 Nov 2004 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- JIX
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.1150
- Advisory Committee
- Clinical Chemistry
- FDA Decision
- SESE Substantially Equivalent
Other devices from Wako Chemicals USA, Inc.
Questions
What is the Multi-Lipid Calibrator used for?
This device is a multi-analyte mixture intended for clinical laboratories to calibrate analytical instruments for measuring cholesterol, HDL, LDL, and triglyceride levels in patient samples.
Is the Multi-Lipid Calibrator sterile?
No, the device is not sterile and does not require storage under specific conditions beyond standard laboratory practices.
Can the Multi-Lipid Calibrator be reused?
The device is supplied as a single-use calibrator and is not reusable.
What instruments is the Multi-Lipid Calibrator intended for?
It is intended for use with specific HDL-C and LDL-C reagents.