ARCHITECT C-PEPTIDE CALIBRATORS, AND ARCHITECT C-PEPTIDE CONTROLS, MODELS 3L53-01, 3L53-10— 510(k) K082141
Substantially EquivalentBiokit, S.A.
FDA 510(k) clearance K082141 for ARCHITECT C-PEPTIDE CALIBRATORS, AND ARCHITECT C-PEPTIDE CONTROLS, MODELS 3L53-01, 3L53-10, Substantially Equivalent on 2008-09-03. Applicant: Biokit, S.A.. Device class: 2.
Clearance details
- Applicant
- Biokit, S.A.
- Product code
- Code JIT
- Device class
- Class 2
- Regulation
- 21 CFR 862.1150
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- Barcelona, ES
Recent devices under product code JIT
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