510(k) K780495
- Device
- Digitoxin
- Applicant
- DIAGNOSTIC PRODUCTS CORP.
- 510(k) number
- K780495
- Product code
- DJK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1978-04-10
- Date received
- 1978-03-27
- Regulation
- 862.3280
- Classification name
- Digitoxin Control Serum, Ria
- Medical specialty
- Clinical Toxicology
- Review panel
- Clinical Toxicology
- Device class
- 1
- 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