CHG · Acid, Phosphoric-Tungstic (Spectrophotometric), Chloride
Clinical Chemistry · 21 CFR 862.1170 · Class 2
Overview
| Product Code | CHG |
|---|---|
| Device Name | Acid, Phosphoric-Tungstic (Spectrophotometric), 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.
Cleared Devices (3)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K941807 | INTERSECT SYSTEMS' NON-MERCURIC CHLORIDE REAGENT | Intersect Systems, Inc. | Sep 14, 1994 | SESE |
| K934588 | CHLORIDE (MF) ASSAY | Diagnostic Chemicals , Ltd. | Feb 18, 1994 | SESE |
| K903103 | SYNERMED CHLORIDE REAGENT KIT | Synermed, Inc. | Aug 9, 1990 | SESE |
Top Applicants
- Synermed, Inc. — 1 clearance
- Intersect Systems, Inc. — 1 clearance
- Diagnostic Chemicals , Ltd. — 1 clearance
