DAC-CEL DIGOXIN RADIOIMMUNOASSAY KIT— 510(k) K780475
Substantially EquivalentBurroughs Wellcome Co.
FDA 510(k) clearance K780475 for DAC-CEL DIGOXIN RADIOIMMUNOASSAY KIT, Substantially Equivalent on 1978-04-24. Applicant: Burroughs Wellcome Co.. Device class: 2.
Clearance details
- Applicant
- Burroughs Wellcome Co.
- Product code
- Code DON
- Device class
- Class 2
- Regulation
- 21 CFR 862.3320
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
Recent devices under product code DON
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