HEVYLITE HUMAN IGA KAPPA KIT FOR USE ON SIEMENS BNII, HEVYLITE HUMAN IGA LAMBDA KIT FOR USE ON SIEMENS BNII— 510(k) K140105

Name: FDA 510(k) clearance K140105
Creator: U.S. Food and Drug Administration
Published: 2014-03-18

Substantially Equivalent

The Binding Site

FDA 510(k) clearance K140105 for HEVYLITE HUMAN IGA KAPPA KIT FOR USE ON SIEMENS BNII, HEVYLITE HUMAN IGA LAMBDA KIT FOR USE ON SIEMENS BNII, Substantially Equivalent on 2014-03-18. Applicant: The Binding Site. Device class: 2.

Clearance details

Applicant: The Binding Site
Product code: Code OPX
Device class: Class 2
Regulation: 21 CFR 866.5510
Advisory panel: Immunology
Date received: 2014-01-15
Decision date: 2014-03-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Birmingham, GB

Download summary PDF View on FDA.gov ↗

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