Direct Glucose Reagent Set
FDA 510(k) K821198 · Omega Medical Electronics
510(k) numberK821198
Submission
- Device name
- Direct Glucose Reagent Set
- Applicant
- Omega Medical Electronics
Mchenry, IL, US - Received
- April 27, 1982
- Decision date
- July 13, 1982
- 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 |
| 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 |
| K781308 | GlucolourCGE · Traditional | Analytical & Research Chemicals, Inc. | 08/31/1978SE |
| 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 |
|---|---|---|
| K823691 | Phosphorus Reagent SetCEO · Traditional | 01/07/1983SE |
| K821212 | Urea Nitrogen Reagent SetCDW · Traditional | 07/22/1982SE |
| K821206 | Sgpt-Uv Reagent SetCKA · Traditional | 07/22/1982SE |
| K821204 | Glucose(Enzymatic) Reagent SetCGA · Traditional | 07/22/1982SE |
| K821208 | Sgot-Uv Reagent SetCIT · Traditional | 07/20/1982SE |
| K821205 | Triglyceride Reagent SetCDT · Traditional | 07/20/1982SE |
| K821201 | Ldh-Uv Reagent SetCFJ · Traditional | 07/20/1982SE |
| K821209 | Sgot Reagent SetCIQ · Traditional | 07/14/1982SE |
| K821207 | SGPT Reagent SetCKD · Traditional | 07/14/1982SE |
| K821213 | Uric Acid Reagent SetCDH · Traditional | 07/13/1982SE |
Questions and answers
When was Direct Glucose Reagent Set cleared by the FDA?
Direct Glucose Reagent Set (K821198) received a 510(k) decision of Substantially Equivalent on July 13, 1982, 77 days after the submission was received.
What is the product code of K821198?
The FDA product code is CGE – Orthotoluidine, Glucose, a Class II (moderate risk) device regulated under 21 CFR 862.1345.