QUANTIA LA(A)— 510(k) K050487

Substantially Equivalent

Biokit, S.A.

FDA 510(k) clearance K050487 for QUANTIA LA(A), Substantially Equivalent on 2005-04-26. Applicant: Biokit, S.A.. Device class: 2.

Clearance details

Applicant: Biokit, S.A.
Product code: Code DFC
Device class: Class 2
Regulation: 21 CFR 866.5600
Advisory panel: Immunology
Date received: 2005-02-25
Decision date: 2005-04-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Barcelona, ES

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.