CHK · Mercuric Nitrate And Diphenyl Carbazone (Titrimetric), Chloride
Clinical Chemistry · 21 CFR 862.1170 · Class 2
Overview
| Product Code | CHK |
|---|---|
| Device Name | Mercuric Nitrate And Diphenyl Carbazone (Titrimetric), Chloride |
| Regulation | 21 CFR 862.1170 |
| Device Class | Class 2 |
| Review Panel | Clinical Chemistry |
| 3rd-Party Reviewable | Yes |
Identification
A chloride test system is a device intended to measure the level of chloride in plasma, serum, sweat, and urine. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.
Classification Rationale
Class II.
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K870214 | MODIFIED SALTEX REAGENT STRIPS | Miles Laboratories, Inc. | Jun 29, 1987 | SESE |
Top Applicants
- Miles Laboratories, Inc. — 1 clearance
