510(k) K802615
- Device
- Emit-stm Opiate Assay
- Applicant
- SYVA CO.
- 510(k) number
- K802615
- Product code
- DJE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1980-10-31
- Date received
- 1980-10-20
- Regulation
- 862.3830
- Classification name
- Thin Layer Chromatography, Salicylate
- 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
Source Documents#
510(k) summary PDF not indicated by FDA