Mercuric Nitrate And Diphenyl Carbazone (Titrimetric), Chloride
The Mercuric Nitrate and Diphenyl Carbazone (Titrimetric), Chloride test system (product code CHK) is an in-vitro diagnostic device used in clinical chemistry to measure chloride concentrations in biological specimens using a titrimetric method involving mercuric nitrate and diphenyl carbazone indicator. It is classified as FDA Class 2, indicating moderate risk, and requires a 510(k) premarket notification. It falls under regulation 21 CFR 862.1170 in the Clinical Chemistry medical specialty. This device is eligible for third-party review under the FDA's accredited persons program.
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Basic Information
- Product Code
- CHK
- Device Class
- FDA class 2
- Regulation Number
- 862.1170
- Medical Specialty
- Clinical Chemistry
- Review Panel
- CH
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K870214 | MODIFIED SALTEX REAGENT STRIPS | Jun 29, 1987 | Substantially Equivalent | Miles Laboratories, Inc. |