Glucolour
FDA 510(k) K781308 · Analytical & Research Chemicals, Inc.
510(k) numberK781308
Submission
- Device name
- Glucolour
- Applicant
- Analytical & Research Chemicals, Inc.
Mchenry, IL, US - Received
- July 28, 1978
- Decision date
- August 31, 1978
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CGE – Orthotoluidine, Glucose
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1345
- Specialty
- Clinical Chemistry
Other 510(k)s with product code CGE
| 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 |
| K771314 | Glucose Reagent (O-Toluidine)CGE · Traditional | Mallinckrodt Critical Care | 08/03/1977SE |
| K771091 | Unipak GlucoseCGE · Traditional | Harleco | 07/21/1977SE |
More from Harleco
| 510(k) | Device | Decision |
|---|---|---|
| K823806 | Direct Creatinine ProcedureCGX · Traditional | 01/14/1983SE |
| K823786 | Alkaline PhosphataseCJE · Traditional | 01/14/1983SE |
| K823784 | Enzymatic Cholesterol (ColorimetricCHH · Traditional | 01/14/1983SE |
| K781460 | Chloride ReagentCHJ · Traditional | 10/10/1978SE |
| K781441 | BCG Albumin ReagetCIX · Traditional | 10/10/1978SE |
| K781324 | Alp TestCIO · Traditional | 08/31/1978SE |
| K781323 | LDH Procedure · Traditional | 08/31/1978SE |
| K781309 | Got Procedure · Traditional | 08/31/1978SE |
| K781307 | Glucose Determ. KitCGA · Traditional | 08/31/1978SE |
| K781306 | Urea Nitrogen Test KitCDL · Traditional | 08/31/1978SE |
Questions and answers
When was Glucolour cleared by the FDA?
Glucolour (K781308) received a 510(k) decision of Substantially Equivalent on August 31, 1978, 34 days after the submission was received.
What is the product code of K781308?
The FDA product code is CGE – Orthotoluidine, Glucose, a Class II (moderate risk) device regulated under 21 CFR 862.1345.