510(k) K781941
- Device
- Analysis System, Prep Sample
- Applicant
- E.I. DUPONT DE NEMOURS & CO., INC.
- 510(k) number
- K781941
- Product code
- DOZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1979-01-03
- Date received
- 1978-11-20
- Regulation
- 862.3350
- Classification name
- Liquid Chromatography, Diphenylhydantoin
- 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