KALLESTAD QUANTICOAT 125 DIGOXIN— 510(k) K811776
Substantially EquivalentKallestad Laboratories, Inc.
FDA 510(k) clearance K811776 for KALLESTAD QUANTICOAT 125 DIGOXIN, Substantially Equivalent on 1981-07-10. Applicant: Kallestad Laboratories, Inc.. Device class: 2.
Clearance details
- Applicant
- Kallestad Laboratories, Inc.
- Product code
- Code DPO
- 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
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