Acs Cholestrerol/Triglyceride Liquid Linear Calibr
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K904767 FDA 510(k)
- FDA Product Code
- JIX FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 862.1150 FDA 510(k)
- Regulation Number
- 862.1150 FDA 510(k)
- Advisory Committee
- Clinical Chemistry FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
This device is a calibrator, multi-analyte mixture, used in clinical chemistry for the calibration of assays measuring cholesterol and triglycerides. It is a liquid formulation designed to provide a known concentration reference for accurate quantification in laboratory testing.
It is supplied as a liquid calibrator for in vitro diagnostic use, intended for use in clinical laboratory settings. The device is regulated under 21 CFR 862.1150 and was cleared via the FDA 510(k) pathway (K904767) on December 26, 1990, as substantially equivalent to a predicate device.
Frequently asked questions
What is the ACS CHOLESTREROL/TRIGLYCERIDE LIQUID LINEAR CALIBR used for?
This device is a multi-analyte liquid calibrator used in clinical chemistry to calibrate assays that measure cholesterol and triglycerides. It provides a known concentration reference to ensure accurate quantification of these analytes in patient samples during laboratory testing. It is intended for in vitro diagnostic use in clinical laboratory settings.
How is the ACS CHOLESTREROL/TRIGLYCERIDE LIQUID LINEAR CALIBR supplied and what is its physical form?
The device is supplied as a liquid formulation, specifically a multi-analyte mixture in liquid form, designed for use as a calibrator in clinical chemistry testing. It is provided in a liquid state to allow for direct use or dilution as needed in laboratory workflows for calibrating cholesterol and triglyceride assays.
What regulatory pathway was used to clear the ACS CHOLESTREROL/TRIGLYCERIDE LIQUID LINEAR CALIBR, and when was it cleared?
The device was cleared via the FDA 510(k) pathway under submission number K904767, with a decision date of December 26, 1990. It was determined to be substantially equivalent to a predicate device and is regulated under 21 CFR 862.1150 for calibrators in clinical chemistry.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: K904767 FDA 510(k) - ACS CHOLESTREROL/TRIGLYCERIDE LIQUID LI..., PDF K904767 Acs Cholestrerol/Triglyceride Liquid Linear Calibr, Analytical Control Systems, Inc., ACS CHOLESTEROL/TRIGLYCERIDE LIQUID CONTROL (K904829) — FDA 510(k ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K904767 | Class II | Active |
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Manufacturer
- Manufacturer
- Analytical Control Systems Inc
- FDA Applicant
- Analytical Control Systems, Inc.
Sources (1)
- FDA 510(k) K904767 24 fields · synced Sep 19, 2026