Ortho-Toluidine Reagent Set
FDA 510(k) K790319 · Fisher Scientific Co., LLC
510(k) numberK790319
Submission
- Device name
- Ortho-Toluidine Reagent Set
- Applicant
- Fisher Scientific Co., LLC
Mchenry, IL, US - Received
- February 15, 1979
- Decision date
- March 21, 1979
- 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 |
| 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 |
|---|---|---|
| K930415 | Microhematocrit RotorGKG · Traditional | 03/23/1993SE |
| K915825 | Marathon 6K General-Purpose CentrifugeGKF · Traditional | 03/11/1992SE |
| K915441 | Marathon 13K/H Microhematocrit CentrifugeGKF · Traditional | 01/08/1992SE |
| K890534 | Modified Uriqual(Tm) Urinalysis Control Level 1JJW · Traditional | 03/08/1989SE |
| K881275 | Uriqual(Tm) Urinalysis Controls (Human) I & IIJJY · Traditional | 05/16/1988SE |
| K874054 | Fisher Diagnostics Hematall III Las ReagentGGK · Traditional | 10/20/1987SE |
| K872916 | Histomatic Slide Stainer, Code-On VersionKPA · Traditional | 09/14/1987SE |
| K871058 | Serachem Liquid Spinal Fluid Control (Human)JJY · Traditional | 04/06/1987SE |
| K863224 | Hematall-C Plus Hematology ControlsJPK · Traditional | 10/29/1986SE |
| K862318 | Fisher Diagnostics Hematall-C CalibratorJPK · Traditional | 07/10/1986SE |
Questions and answers
When was Ortho-Toluidine Reagent Set cleared by the FDA?
Ortho-Toluidine Reagent Set (K790319) received a 510(k) decision of Substantially Equivalent on March 21, 1979, 34 days after the submission was received.
What is the product code of K790319?
The FDA product code is CGE – Orthotoluidine, Glucose, a Class II (moderate risk) device regulated under 21 CFR 862.1345.