CGE
12 FDA 510(k) clearances · Product code
34 daysmedian time to decision
77 days90th percentile
12clearances measured
FDA profile
- Official device name
- Orthotoluidine, Glucose
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1345
- Medical specialty
- Clinical Chemistry
- Flags
- Third-party review eligible
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| SODIUM HYDROXIDE SOLUTION, CREATININE REAG./DILU. (K890335) | Alpkem Corp. | 1989-02-17 |
| GLUCOSE REAGENT SET (K855185) | Technostics Intl. | 1986-01-22 |
| GLUCOSE (K850930) | Dilab, Inc. | 1985-06-10 |
| DIRECT GLUCOSE REAGENT SET (K841054) | Medical Specialties, Inc. | 1984-05-01 |
| DIRECT GLUCOSE REAGENT SET (K821198) | Omega Medical Electronics | 1982-07-13 |
| KING DIAGNOSTICS GLUCOSE-O TEST (K811883) | King Diagnostics, Inc. | 1981-07-23 |
| 6% ORTHO LOLIUDINE REAGENT IN GLACID ACI (K810089) | Anco Medical Reagents & Assoc. | 1981-01-26 |
| ORTHO-TOLUIDINE REAGENT SET (K790319) | Fisher Scientific Co., LLC | 1979-03-21 |
| GLUCOLOUR (K781308) | Analytical & Research Chemicals, Inc. | 1978-08-31 |
| GLUCOSE REAGENT (O-TOLUIDINE) (K771314) | Mallinckrodt Critical Care | 1977-08-03 |
| UNIPAK GLUCOSE (K771091) | Harleco | 1977-07-21 |
| GLUCOSE PROCEDURE, TEKPOINT DIRECT (K770455) | Icn Pharmaceuticals, Inc. | 1977-05-03 |
Track CGE automatically
Every clearance here is in the API, with alerts when new ones post.