MRI Gentamicin Ria Kit
FDA 510(k) K812394 · Microanalytic Research, Inc.
510(k) numberK812394
Submission
- Device name
- MRI Gentamicin Ria Kit
- Applicant
- Microanalytic Research, Inc.
Mchenry, IL, US - Received
- August 20, 1981
- Decision date
- September 8, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DJB – Radioimmunoassay, Gentamicin (125-I), Second Antibody Sep.
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3450
- Specialty
- Clinical Toxicology
Other 510(k)s with product code DJB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K832792 | Ames Tda Sisomicin Test-Control SerumDJB · Traditional | Miles Laboratories, Inc. | 09/29/1983SE |
| K831210 | Gentamicin Test Pack-AcaDJB · Traditional | E.I. Dupont DE Nemours & Co., Inc. | 05/25/1983SE |
| K821669 | Ames Tda Gentamicin TestDJB · Traditional | Miles Laboratories, Inc. | 12/15/1982SE |
| K811844 | Coat-A-Count Gentamicin Ria KitDJB · Traditional | Diagnostic Products Corp. | 07/10/1981SE |
| K800537 | Gamma Stick Gentamicin Ria KitDJB · Traditional | Alpha Gamma Laboratory | 04/24/1980SE |
| K791770 | Quantimune Gentamicin Ria GentamicinDJB · Traditional | Bio-Rad | 10/17/1979SE |
| K791547 | Fluoromatic Gentamicin Fia ImmunoassayDJB · Traditional | Bio-Rad | 10/12/1979SE |
| K782049 | Bioassay System, MS-2 SerumDJB · Traditional | Abbott Laboratories | 08/28/1979SE |
| K790584 | Ames Tda/GentgmicinDJB · Traditional | Miles Laboratories, Inc. | 06/15/1979SE |
| K790829 | Emit Gentamicin AssayDJB · Traditional | Syva Co. | 05/15/1979SE |
More from Syva Co.
| 510(k) | Device | Decision |
|---|---|---|
| K861097 | Trypsin Ria KitJNO · Traditional | 05/29/1986SE |
| K820741 | MR1 Lutropin Ria KitCEP · Traditional | 04/14/1982SE |
| K820740 | MR1 Follitropin Ria KitCGJ · Traditional | 04/06/1982SE |
| K813516 | MRI Tobramycin Ria KitKLB · Traditional | 12/29/1981SE |
| K810949 | MRI Prolactin Ria KitCFT · Traditional | 07/10/1981SE |
| K802754 | Immunoreactive Estriol Ria KitCGI · Traditional | 01/21/1981SE |
| K801491 | MRI Hcg-Beta Ria Kit Cat. #MR-10100JHI · Traditional | 08/13/1980SE |
Questions and answers
When was MRI Gentamicin Ria Kit cleared by the FDA?
MRI Gentamicin Ria Kit (K812394) received a 510(k) decision of Substantially Equivalent on September 8, 1981, 19 days after the submission was received.
What is the product code of K812394?
The FDA product code is DJB – Radioimmunoassay, Gentamicin (125-I), Second Antibody Sep., a Class II (moderate risk) device regulated under 21 CFR 862.3450.