ARCHITECT IVANCOMYCIN— 510(k) K123947
Substantially EquivalentBiokit, S.A.
FDA 510(k) clearance K123947 for ARCHITECT IVANCOMYCIN, Substantially Equivalent on 2013-08-29. Applicant: Biokit, S.A.. Device class: 2.
Clearance details
- Applicant
- Biokit, S.A.
- Product code
- Code LEH
- Device class
- Class 2
- Regulation
- 21 CFR 862.3950
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Llissa D'Amunt, Barcelona, ES
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