510(k) K780075
- Device
- Rialyze Digoxin
- Applicant
- MILES LABORATORIES, INC.
- 510(k) number
- K780075
- Product code
- DPG
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1978-02-28
- Date received
- 1978-01-16
- Regulation
- 862.3300
- Classification name
- Radioimmunoassay, Digitoxin (125-I), Rabbit Antibody, Coated Tube Sep.
- 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