LP(A) CALIBRATORS, AND LP(A) CONTROLS— 510(k) K132400

Name: FDA 510(k) clearance K132400
Creator: U.S. Food and Drug Administration
Published: 2013-12-19

Substantially Equivalent

Biokit, S.A.

FDA 510(k) clearance K132400 for LP(A) CALIBRATORS, AND LP(A) CONTROLS, Substantially Equivalent on 2013-12-19. 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: 2013-08-01
Decision date: 2013-12-19
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Llissa D'Amunt, Barcelona, ES

Download summary PDF View on FDA.gov ↗

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