FDA Product Code
FDA Product Code CGE — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1345
510(k) Clearances — 12 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K890335 | SODIUM HYDROXIDE SOLUTION, CREATININE REAG./DILU. | Alpkem Corp. | 1989-02-17 | Traditional | PDF ↗ |
| K855185 | GLUCOSE REAGENT SET | Technostics Intl. | 1986-01-22 | Traditional | PDF ↗ |
| K850930 | GLUCOSE | Dilab, Inc. | 1985-06-10 | Traditional | PDF ↗ |
| K841054 | DIRECT GLUCOSE REAGENT SET | Medical Specialties, Inc. | 1984-05-01 | Traditional | PDF ↗ |
| K821198 | DIRECT GLUCOSE REAGENT SET | Omega Medical Electronics | 1982-07-13 | Traditional | PDF ↗ |
| K811883 | KING DIAGNOSTICS GLUCOSE-O TEST | King Diagnostics, Inc. | 1981-07-23 | Traditional | PDF ↗ |
| K810089 | 6% ORTHO LOLIUDINE REAGENT IN GLACID ACI | Anco Medical Reagents & Assoc. | 1981-01-26 | Traditional | PDF ↗ |
| K790319 | ORTHO-TOLUIDINE REAGENT SET | Fisher Scientific Co., LLC | 1979-03-21 | Traditional | PDF ↗ |
| K781308 | GLUCOLOUR | Analytical & Research Chemicals, Inc. | 1978-08-31 | Traditional | PDF ↗ |
| K771314 | GLUCOSE REAGENT (O-TOLUIDINE) | Mallinckrodt Critical Care | 1977-08-03 | Traditional | PDF ↗ |
| K771091 | UNIPAK GLUCOSE | Harleco | 1977-07-21 | Traditional | PDF ↗ |
| K770455 | GLUCOSE PROCEDURE, TEKPOINT DIRECT | Icn Pharmaceuticals, Inc. | 1977-05-03 | Traditional | PDF ↗ |
Product code CGE · Class II · Clinical Chemistry. Data: openFDA.