510(k) K863888
- Device
- Du Pont Phenytoin Assay And Calibrator
- Applicant
- E.I. DUPONT DE NEMOURS & CO., INC.
- 510(k) number
- K863888
- Product code
- DIR
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1986-11-05
- Date received
- 1986-10-06
- Regulation
- 862.3250
- Classification name
- Free Radical Assay, Cocaine
- Medical specialty
- Clinical Toxicology
- Review panel
- Clinical Toxicology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- N
Related Records
Applicant Contact
- Contact
- RICHARD M VAUGHT
- Address
- Medical Products Dept. Barley Mill Plz., P22-1170 Wilmington DE US 19898 19898
Source Documents
510(k) summary PDF not indicated by FDA