Glucose Reagent (O-Toluidine)
FDA 510(k) K771314 · Mallinckrodt Critical Care
510(k) numberK771314
Submission
- Device name
- Glucose Reagent (O-Toluidine)
- Applicant
- Mallinckrodt Critical Care
Mchenry, IL, US - Received
- July 18, 1977
- Decision date
- August 3, 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 |
| K771091 | Unipak GlucoseCGE · Traditional | Harleco | 07/21/1977SE |
More from Harleco
| 510(k) | Device | Decision |
|---|---|---|
| K880343 | Burney Gallbladder Catheter KitFGE · Traditional | 05/01/1989SE |
| K874605 | Hi-Lo Temp(R) Myocardial Temperature SensorKRI · Traditional | 02/02/1988SE |
| K874514 | Hi-Lo Temp(R) General Purpose Temperature ProbeFLL · Traditional | 01/29/1988SE |
| K874568 | Hi-Lo Temp(R) Model 8700 Patient Temp MonitorFLL · Traditional | 01/06/1988SE |
| K874404 | Hi-Lo Temp(R) Skin Temperature SensorFLL · Traditional | 11/06/1987SE |
| K873461 | Laser-Flex(Tm) Tracheal Tube (Cuffed)BTR · Traditional | 11/06/1987SE |
| K873833 | Thermocouple AdapterFLL · Traditional | 11/03/1987SE |
| K873004 | Guiding CatheterDQO · Traditional | 09/15/1987SE |
| K871204 | Cuffed Tracheal Tube (Multiple)BTR · Traditional | 04/21/1987SE |
| K862666 | Uncuffed Laser Resisteant Tracheal Tube(Tentative)BTR · Traditional | 08/01/1986SE |
Questions and answers
When was Glucose Reagent (O-Toluidine) cleared by the FDA?
Glucose Reagent (O-Toluidine) (K771314) received a 510(k) decision of Substantially Equivalent on August 3, 1977, 16 days after the submission was received.
What is the product code of K771314?
The FDA product code is CGE – Orthotoluidine, Glucose, a Class II (moderate risk) device regulated under 21 CFR 862.1345.