AXSYM DIGOXIN III— 510(k) K061249
Substantially EquivalentAbbott Laboratories
FDA 510(k) clearance K061249 for AXSYM DIGOXIN III, Substantially Equivalent on 2006-06-02. Applicant: Abbott Laboratories. Device class: 2.
Clearance details
- Applicant
- Abbott Laboratories
- Product code
- Code KXT
- Device class
- Class 2
- Regulation
- 21 CFR 862.3320
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Abbott Park, IL, US
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