Acid, Phosphoric-Tungstic (Spectrophotometric), Chloride
The Phosphoric-Tungstic Acid (Spectrophotometric), Chloride test system (product code CHG) is an in-vitro diagnostic device used in clinical chemistry to measure chloride concentrations in serum, plasma, or urine using a spectrophotometric method based on phosphoric-tungstic acid chemistry. 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
- CHG
- 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 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K941807 | INTERSECT SYSTEMS' NON-MERCURIC CHLORIDE REAGENT | Sep 14, 1994 | Substantially Equivalent | Intersect Systems, Inc. |
| K934588 | CHLORIDE (MF) ASSAY | Feb 18, 1994 | Substantially Equivalent | Diagnostic Chemicals , Ltd. |
| K903103 | SYNERMED CHLORIDE REAGENT KIT | Aug 09, 1990 | Substantially Equivalent | Synermed, Inc. |
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.