Product code LDN
- Device name
- Enzymatic Radiochemical Assay, Amikacin
- Medical specialty
- Clinical Toxicology
- Device class
- 2
- Regulation number
- 862.3035
- Review panel
- TX
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records
| 510(k) | Device | Applicant | Decision date |
|---|
| K840647 | AMIKACIN REAGENT TEST KIT | Beckman Instruments, Inc. | 1984-04-02 |
| K833546 | MODIFICATION OF EMIT AND AMIKACIN ASSAY | Syva Co. | 1983-12-08 |
| K820440 | EMIT-AMD AMIKACIN CONTR. (ENZYME IMMUNO | Syva Co. | 1982-03-15 |