DUPONT ACA DIGOXIN (DGN A) METHOD— 510(k) K951441
Substantially EquivalentE.I. Dupont DE Nemours & Co., Inc.
FDA 510(k) clearance K951441 for DUPONT ACA DIGOXIN (DGN A) METHOD, Substantially Equivalent on 1995-06-01. Applicant: E.I. Dupont DE Nemours & Co., Inc.. Device class: 2.
Clearance details
- Applicant
- E.I. Dupont DE Nemours & Co., Inc.
- 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
- Traditional
- Location
- Wilmington, DE, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.