Reagent for Determ. Chloride in Human/Sm
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K800683 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)
This device is a reagent for determining chloride in human serum or plasma. It is used in clinical chemistry for the quantitative measurement of chloride ions.
The reagent is supplied for in vitro diagnostic use and is intended for use in laboratory settings. It is regulated under FDA 510(k) clearance (K800683) and classified as a Class II device under regulation number 862.1170 with product code CHJ.
Frequently asked questions
What is this reagent used for?
This reagent is used for the quantitative measurement of chloride ions in human serum or plasma. It is intended for in vitro diagnostic use in clinical chemistry laboratories to determine chloride concentration as part of electrolyte panel testing.
How is this reagent supplied and what is its intended use environment?
The reagent is supplied for in vitro diagnostic use and is intended for use in laboratory settings. It is designed for clinical chemistry applications where quantitative chloride measurement is required from human serum or plasma samples.
What regulatory pathway was used for this device and what is its classification?
This device was cleared through the FDA 510(k) process under submission K800683 and is classified as a Class II medical device under regulation number 862.1170 with product code CHJ, indicating substantial equivalence to a legally marketed predicate device.
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: Different Types Of Chemical Reagents And Their Uses
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K800683 | Class II | Active |
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Manufacturer
- Manufacturer
- Diagnostic Solutions, Inc.
Sources (1)
- FDA 510(k) K800683 24 fields · synced Sep 21, 2026