510(k) K820900
- Device
- Emit Urine Methadone Assay #3e319
- Applicant
- SYVA CO.
- 510(k) number
- K820900
- Product code
- DDE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1982-04-26
- Date received
- 1982-03-31
- Regulation
- 866.5200
- Classification name
- Carbonic Anhydrase C, Antigen, Antiserum, Control
- Medical specialty
- Immunology
- Review panel
- Immunology
- Device class
- 1
- 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