510(k) K780442
- Device
- Theophylline Assay To The Gemsaec
- Applicant
- SYVA CO.
- 510(k) number
- K780442
- Product code
- LCY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1978-04-12
- Date received
- 1978-03-20
- Regulation
- 862.3880
- Classification name
- U.V. Spectrometry, Theophylline
- 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#
- 1181121
Source Documents#
510(k) summary PDF not indicated by FDA