Emit Gentamicin Assay
FDA 510(k) K790829 · Syva Co.
510(k) numberK790829
Submission
- Device name
- Emit Gentamicin Assay
- Applicant
- Syva Co.
Mchenry, IL, US - Received
- April 30, 1979
- Decision date
- May 15, 1979
- 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 |
| 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 |
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| K011947 | Emit 2000 Valproic Acid Assay, Model OSR4G229ULLEG · Special | 07/02/2001SE |
| K011528 | Emit 2000 Phenobarbital Assay, Model OSR4D229DLZ · Special | 06/06/2001SE |
| K011347 | Emit 2000 Phenytoin Assay, Model 0SR4A229DIP · Special | 05/17/2001SE |
| K993981 | Syva Emit II Plus Propoxyphene Assay, Models 9G029UL/9G129ULJXN · Traditional | 02/01/2000SE |
| K993980 | Syva Emit II Plus Ethyl Alcohol Assay, Models 9K309UL/9K409ULDML · Traditional | 02/01/2000SE |
| K993988 | Syva Emit II Plus Cocaine Metabolite Assay, Model 9H029ULDIO · Traditional | 01/27/2000SE |
| K993987 | Syva Emit II Plus Barbiturate Assay, Model 9D029UL/9D129ULKLT · Traditional | 01/27/2000SE |
| K993986 | Syva Emit II Plus Methaqualone Assay, Model 9Q029UL/9Q129ULKXS · Traditional | 01/27/2000SE |
Questions and answers
When was Emit Gentamicin Assay cleared by the FDA?
Emit Gentamicin Assay (K790829) received a 510(k) decision of Substantially Equivalent on May 15, 1979, 15 days after the submission was received.
What is the product code of K790829?
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.