510(k) K832055
- Device
- Emit Assay And Tobramycin
- Applicant
- SYVA CO.
- 510(k) number
- K832055
- Product code
- LDO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1983-08-08
- Date received
- 1983-06-27
- Regulation
- 862.3900
- Classification name
- Enzymatic Radiochemical Assay, Tobramycin
- Medical specialty
- Clinical Toxicology
- Review panel
- Clinical Toxicology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 2432235
- 2250051
- 3012963943
- 1319681
- 3000308930
- 2517506
- 1319808
- 3002642396
Source Documents#
510(k) summary PDF not indicated by FDA