CGE — Orthotoluidine, Glucose Class II
FDA product code CGE covers "Orthotoluidine, Glucose", a Class II medical device regulated under 21 CFR 862.1345. Submissions are reviewed by the Clinical Chemistry panel. At least 12 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- CGE
- Device Class
- Class II
- Regulation Number
- 862.1345
- Submission Type
- Review Panel
- CH
- Medical Specialty
- Clinical Chemistry
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K890335 | alpkem | SODIUM HYDROXIDE SOLUTION, CREATININE REAG./DILU. | February 17, 1989 |
| K855185 | technostics intl | GLUCOSE REAGENT SET | January 22, 1986 |
| K850930 | dilab | GLUCOSE | June 10, 1985 |
| K841054 | medical specialties | DIRECT GLUCOSE REAGENT SET | May 1, 1984 |
| K821198 | omega medical electronics | DIRECT GLUCOSE REAGENT SET | July 13, 1982 |
| K811883 | king diagnostics | KING DIAGNOSTICS GLUCOSE-O TEST | July 23, 1981 |
| K810089 | anco medical reagents and assoc | 6% ORTHO LOLIUDINE REAGENT IN GLACID ACI | January 26, 1981 |
| K790319 | fisher scientific co | ORTHO-TOLUIDINE REAGENT SET | March 21, 1979 |
| K781308 | analytical and research chemicals | GLUCOLOUR | August 31, 1978 |
| K771314 | mallinckrodt critical care | GLUCOSE REAGENT (O-TOLUIDINE) | August 3, 1977 |
| K771091 | harleco | UNIPAK GLUCOSE | July 21, 1977 |
| K770455 | icn pharmaceuticals | GLUCOSE PROCEDURE, TEKPOINT DIRECT | May 3, 1977 |