Product code CGE— Clinical Chemistry
DIRECT GLUCOSE REAGENT SET
- Classification name
- Orthotoluidine, Glucose
- Device class
- Class 2
- Regulation
- 21 CFR 862.1345
- Advisory panel
- Clinical Chemistry
- Total cleared
- 12
- First cleared
- Most recent
Market context for product code CGE
FDA has cleared devices under product code CGE between 1977 and 1989, filed by 12 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 1989
- 1986
- 1985
- 1984
- 1982
- 1981
- 1979
- 1978
- 1977
Top applicants under product code CGE
Recent clearances under product code CGE
- K890335 — SODIUM HYDROXIDE SOLUTION, CREATININE REAG./DILU.
- K855185 — GLUCOSE REAGENT SET
- K850930 — GLUCOSE
- K841054 — DIRECT GLUCOSE REAGENT SET
- K821198 — DIRECT GLUCOSE REAGENT SET
- K811883 — KING DIAGNOSTICS GLUCOSE-O TEST
- K810089 — 6% ORTHO LOLIUDINE REAGENT IN GLACID ACI
- K790319 — ORTHO-TOLUIDINE REAGENT SET
- K781308 — GLUCOLOUR
- K771314 — GLUCOSE REAGENT (O-TOLUIDINE)
- K771091 — UNIPAK GLUCOSE
- K770455 — GLUCOSE PROCEDURE, TEKPOINT DIRECT
Data sourced from openFDA. This site is unofficial and independent of the FDA.