510(k) K770411
- Device
- DIGI TROL TM-RX & DIGI TROL TM-TX
- Applicant
- Nuclear Medical Laboratories, Inc.
- 510(k) number
- K770411
- Product code
- DMP
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1977-03-16
- Date received
- 1977-03-04
- Regulation
- 862.3280
- Classification name
- Digoxin Control Serum, Ria
- Medical specialty
- Clinical Toxicology
- Review panel
- Clinical Toxicology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- N
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
Source Documents#
510(k) summary PDF not indicated by FDA