Chloride Test Set, Cat.# 0210
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K781635 FDA 510(k)
- FDA Product Code
- CHJ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 862.1170 FDA 510(k)
- Regulation Number
- 862.1170 FDA 510(k)
- Advisory Committee
- Clinical Chemistry FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Chloride Test Set, Cat.# 0210, is a diagnostic in vitro device classified under Mercuric Thiocyanate, Colorimetry, Chloride for measuring chloride ion concentration in clinical chemistry. It employs colorimetric analysis using mercuric thiocyanate to determine chloride levels in patient samples, aiding in the assessment of electrolyte balance and metabolic disorders.
This device is supplied as a ready-to-use liquid reagent kit, requiring no reconstitution or dilution. It is intended for single-use in clinical laboratory settings and has been granted FDA 510(k) clearance under the Substantially Equivalent (SESE) determination. The product adheres to Regulation 862.1170 and is categorized under the Clinical Chemistry medical specialty, with a product code of CHJ. Storage conditions and expiration are specified on the packaging.
Frequently asked questions
What is the Chloride Test Set, Cat.# 0210, used for?
The Chloride Test Set, Cat.# 0210, is an in vitro diagnostic device that measures chloride ion concentration in patient samples using mercuric thiocyanate colorimetry. It aids in assessing electrolyte balance and detecting metabolic disorders by providing quantitative chloride levels in clinical chemistry testing.
How is the Chloride Test Set, Cat.# 0210, supplied and prepared for use?
The device is supplied as a ready-to-use liquid reagent kit that requires no reconstitution or dilution before use. This format allows for immediate application in clinical laboratory settings, reducing preparation time and minimizing potential errors from manual mixing steps.
Is the Chloride Test Set, Cat.# 0210, intended for single-use or reuse?
The Chloride Test Set, Cat.# 0210, is intended for single-use in clinical laboratory settings. This design ensures consistent reagent performance and minimizes the risk of cross-contamination or degradation between tests, supporting reliable and accurate chloride measurements.
What regulatory pathway was used for the Chloride Test Set, Cat.# 0210?
The device received FDA 510(k) clearance through a Traditional submission, with a determination of Substantially Equivalent (SESE). It is classified under product code CHJ and regulated under 21 CFR 862.1170 for mercuric thiocyanate colorimetry chloride tests in the Clinical Chemistry specialty.
Where should the Chloride Test Set, Cat.# 0210, be stored and how is its stability indicated?
Storage conditions and expiration dating for the Chloride Test Set, Cat.# 0210, are specified on the product packaging. Users must refer to the label for exact temperature requirements and shelf life to ensure reagent stability and test accuracy.
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: PDF K781635 - Chloride Test Set, Cat.# 0210, CHLORIDE TEST SET, CAT.# 0210 510(k) K781635 - FDA.report, Stanbio™ Chloride Liquid Reagent for Diagnostic Set, Stanbio Laboratory 0210-250 0210-Series LiquiColor Chloride Test
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K781635 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Stanbio Laboratory
Sources (1)
- FDA 510(k) K781635 24 fields · synced Sep 19, 2026