510(k) K801276
- Device
- Dupont Prep Appli. For Phenobarbital,
- Applicant
- E.I. DUPONT DE NEMOURS & CO., INC.
- 510(k) number
- K801276
- Product code
- DKH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1980-06-20
- Date received
- 1980-05-28
- Regulation
- 862.3350
- Classification name
- Gas Chromatography, Diphenylhydantoin
- 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
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code DKH#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K780733 | ANTICONVULSANTS III CALIBRATOR KIT | Vitek Systems, Inc. | 1978-06-22 |