ARCHITECT IVANCOMYCIN REAGENTS AND ARCHITECT IVANCOMYCIN CALIBRATORS, MODELS: 1P30-25 AND 1P30-01— 510(k) K072036
Substantially EquivalentBiokit, S.A.
FDA 510(k) clearance K072036 for ARCHITECT IVANCOMYCIN REAGENTS AND ARCHITECT IVANCOMYCIN CALIBRATORS, MODELS: 1P30-25 AND 1P30-01, Substantially Equivalent on 2008-03-19. 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
- Barcelona, ES
Recent devices under product code LEH
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