FDA product code CHG: Acid, Phosphoric-Tungstic (Spectrophotometric), Chloride
CHG is the FDA product code for acid, phosphoric-tungstic (spectrophotometric), chloride. It is a Class II device, regulated under 21 CFR 862.1170 and reviewed by the Clinical Chemistry panel. FDA has cleared 3 510(k) submissions under CHG, from 3 different applicants. The average 510(k) review took 110 days (median 148).
Classification
| Field | Value |
|---|---|
| Device name | Acid, Phosphoric-Tungstic (Spectrophotometric), Chloride |
| Device class | Class II |
| Regulation | 21 CFR 862.1170 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every CHG clearance
Top CHG applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Intersect Systems, Inc. | 1 | 1994-09-14 |
| Diagnostic Chemicals , Ltd. | 1 | 1994-02-18 |
| Synermed, Inc. | 1 | 1990-08-09 |
Most recent CHG clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K941807 | Intersect Systems, Inc. | INTERSECT SYSTEMS' NON-MERCURIC CHLORIDE REAGENT | 1994-09-14 | 155 |
| K934588 | Diagnostic Chemicals , Ltd. | CHLORIDE (MF) ASSAY | 1994-02-18 | 148 |
| K903103 | Synermed, Inc. | SYNERMED CHLORIDE REAGENT KIT | 1990-08-09 | 27 |
Recalls for CHG devices
openFDA lists no recalls for product code CHG.
Frequently asked questions
What is FDA product code CHG?
CHG is the FDA product code for acid, phosphoric-tungstic (spectrophotometric), chloride. It is a Class II device, regulated under 21 CFR 862.1170 and reviewed by the Clinical Chemistry panel.
What device class is CHG?
Class II, regulation 21 CFR 862.1170. Typical premarket route: 510(k).
How long does a 510(k) take for product code CHG?
Across 3 cleared submissions the average was 110 days from receipt to decision (median 148).
Which companies have the most CHG clearances?
Intersect Systems, Inc. (1); Diagnostic Chemicals , Ltd. (1); Synermed, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code CHG
- Run a recall and safety report across every CHG manufacturer
- Watch product code CHG for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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