CGE — Orthotoluidine, Glucose Class II
FDA Device Classification
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 |