FDA product code CGE: Orthotoluidine, Glucose
CGE is the FDA product code for orthotoluidine, glucose. It is a Class II device, regulated under 21 CFR 862.1345 and reviewed by the Clinical Chemistry panel. FDA has cleared 12 510(k) submissions under CGE, from 12 different applicants. The average 510(k) review took 40 days (median 34).
Classification
| Field | Value |
|---|---|
| Device name | Orthotoluidine, Glucose |
| Device class | Class II |
| Regulation | 21 CFR 862.1345 |
| 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 CGE clearance
Top CGE applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Alpkem Corp. | 1 | 1989-02-17 |
| Technostics Intl. | 1 | 1986-01-22 |
| Dilab, Inc. | 1 | 1985-06-10 |
| Medical Specialties, Inc. | 1 | 1984-05-01 |
| Omega Medical Electronics | 1 | 1982-07-13 |
7 more applicants have CGE clearances. See the full list in Caduvo.
Most recent CGE clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K890335 | Alpkem Corp. | SODIUM HYDROXIDE SOLUTION, CREATININE REAG./DILU. | 1989-02-17 | 25 |
| K855185 | Technostics Intl. | GLUCOSE REAGENT SET | 1986-01-22 | 27 |
| K850930 | Dilab, Inc. | GLUCOSE | 1985-06-10 | 95 |
| K841054 | Medical Specialties, Inc. | DIRECT GLUCOSE REAGENT SET | 1984-05-01 | 50 |
| K821198 | Omega Medical Electronics | DIRECT GLUCOSE REAGENT SET | 1982-07-13 | 77 |
Recalls for CGE devices
openFDA lists no recalls for product code CGE.
Frequently asked questions
What is FDA product code CGE?
CGE is the FDA product code for orthotoluidine, glucose. It is a Class II device, regulated under 21 CFR 862.1345 and reviewed by the Clinical Chemistry panel.
What device class is CGE?
Class II, regulation 21 CFR 862.1345. Typical premarket route: 510(k).
How long does a 510(k) take for product code CGE?
Across 12 cleared submissions the average was 40 days from receipt to decision (median 34).
Which companies have the most CGE clearances?
Alpkem Corp. (1); Technostics Intl. (1); Dilab, Inc. (1); Medical Specialties, Inc. (1); Omega Medical Electronics (1).
Next steps
- Run an FDA pathway report with predicate devices for product code CGE
- Run a recall and safety report across every CGE manufacturer
- Watch product code CGE 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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