Gentamicin Test Pack-Aca
FDA 510(k) K831210 · E.I. Dupont DE Nemours & Co., Inc.
510(k) numberK831210
Submission
- Device name
- Gentamicin Test Pack-Aca
- Applicant
- E.I. Dupont DE Nemours & Co., Inc.
Mchenry, IL, US - Received
- April 14, 1983
- Decision date
- May 25, 1983
- 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 |
| K821669 | Ames Tda Gentamicin TestDJB · Traditional | Miles Laboratories, Inc. | 12/15/1982SE |
| K812394 | MRI Gentamicin Ria KitDJB · Traditional | Microanalytic Research, Inc. | 09/08/1981SE |
| 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 |
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Questions and answers
When was Gentamicin Test Pack-Aca cleared by the FDA?
Gentamicin Test Pack-Aca (K831210) received a 510(k) decision of Substantially Equivalent on May 25, 1983, 41 days after the submission was received.
What is the product code of K831210?
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.