510(k) K820440
- Device
- Emit-amd Amikacin Contr. (enzyme Immuno
- Applicant
- SYVA CO.
- 510(k) number
- K820440
- Product code
- LDN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1982-03-15
- Date received
- 1982-02-17
- Regulation
- 862.3035
- Classification name
- Enzymatic Radiochemical Assay, Amikacin
- Medical specialty
- Clinical Toxicology
- Review panel
- Clinical Toxicology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- N
Related Records
Applicant Contact
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
Source Documents
510(k) summary PDF not indicated by FDA