Unipak Glucose
FDA 510(k) K771091 · Harleco
510(k) numberK771091
Submission
- Device name
- Unipak Glucose
- Applicant
- Harleco
Mchenry, IL, US - Received
- June 16, 1977
- Decision date
- July 21, 1977
- 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 |
| K781308 | GlucolourCGE · Traditional | Analytical & Research Chemicals, Inc. | 08/31/1978SE |
| K771314 | Glucose Reagent (O-Toluidine)CGE · Traditional | Mallinckrodt Critical Care | 08/03/1977SE |
More from Mallinckrodt Critical Care
| 510(k) | Device | Decision |
|---|---|---|
| K820233 | Ultrazyme Plus Gamma GT(65055-65056)JQB · Traditional | 02/12/1982SE |
| K813427 | Ultrachem Gluc-DhLFR · Traditional | 12/31/1981SE |
| K813044 | Ultrachem Alb, Item #64970CIX · Traditional | 11/10/1981SE |
| K813043 | Ultrachem Crea Item #64972CGX · Traditional | 11/10/1981SE |
| K813042 | Ultrachem Gluc-Dh Set, Item #65048LFR · Traditional | 11/10/1981SE |
| K813041 | Ultrazyme-Gt, Item #64959 & 65032JQB · Traditional | 11/10/1981SE |
| K813040 | Ultrachem Ca, Item #64975CJY · Traditional | 11/10/1981SE |
| K813039 | Ultrachem E-Chol, Item #65025CHH · Traditional | 11/10/1981SE |
| K813038 | Ultrachem TP, Item #64974CEK · Traditional | 11/10/1981SE |
| K812594 | Ultra Zyme Plus Amyl #64982 & 65031CIJ · Traditional | 10/02/1981SE |
Questions and answers
When was Unipak Glucose cleared by the FDA?
Unipak Glucose (K771091) received a 510(k) decision of Substantially Equivalent on July 21, 1977, 35 days after the submission was received.
What is the product code of K771091?
The FDA product code is CGE – Orthotoluidine, Glucose, a Class II (moderate risk) device regulated under 21 CFR 862.1345.