Orthotoluidine, Glucose
FDA product code CGE · Class II (moderate risk) · 21 CFR 862.1345 · Clinical Chemistry
12510(k) clearances
0PMA approvals
0recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K890335 | Sodium Hydroxide Solution, Creatinine Reag./Dilu.CGE · Traditional | Alpkem Corp. | 02/17/1989SE |
| K855185 | Glucose Reagent SetCGE · Traditional | Technostics Intl. | 01/22/1986SE |
| K850930 | GlucoseCGE · Traditional | Dilab, Inc. | 06/10/1985SE |
| K841054 | Direct Glucose Reagent SetCGE · Traditional | Medical Specialties, Inc. | 05/01/1984SE |
| K821198 | Direct Glucose Reagent SetCGE · Traditional | Omega Medical Electronics | 07/13/1982SE |
| K811883 | King Diagnostics Glucose-O TestCGE · Traditional | King Diagnostics, Inc. | 07/23/1981SE |
| K810089 | 6% Ortho Loliudine Reagent in Glacid AciCGE · Traditional | Anco Medical Reagents & Assoc. | 01/26/1981SE |
| K790319 | Ortho-Toluidine Reagent SetCGE · Traditional | Fisher Scientific Co., LLC | 03/21/1979SE |
| K781308 | GlucolourCGE · Traditional | Analytical & Research Chemicals, Inc. | 08/31/1978SE |
| K771314 | Glucose Reagent (O-Toluidine)CGE · Traditional | Mallinckrodt Critical Care | 08/03/1977SE |
| K771091 | Unipak GlucoseCGE · Traditional | Harleco | 07/21/1977SE |
| K770455 | Glucose Procedure, Tekpoint DirectCGE · Traditional | Icn Pharmaceuticals, Inc. | 05/03/1977SE |