510(k) K780734
- Device
- ANTICONVULSANTS II CALIBRATOR KIT
- Applicant
- VITEK SYSTEMS, INC.
- 510(k) number
- K780734
- Product code
- DIY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1978-06-22
- Date received
- 1978-05-02
- Regulation
- 862.3380
- Classification name
- Gas Chromatography, Ethosuximide
- Medical specialty
- Toxicology
- Review panel
- 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
Legacy Summary#
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FDA Review#
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