510(k) K790400
- Device
- Urine Negative Calibrator
- Applicant
- SYVA CO.
- 510(k) number
- K790400
- Product code
- DLT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1979-06-15
- Date received
- 1979-02-26
- Regulation
- 862.3650
- Classification name
- Hemagglutination, Opiates
- 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