FREELITE HUMAN LAMBDA FREE KIT— 510(k) K140396

Name: FDA 510(k) clearance K140396
Creator: U.S. Food and Drug Administration
Published: 2014-04-16

Substantially Equivalent

The Binding Site Group , Ltd.

FDA 510(k) clearance K140396 for FREELITE HUMAN LAMBDA FREE KIT, Substantially Equivalent on 2014-04-16. Applicant: The Binding Site Group , Ltd.. Device class: 2.

Clearance details

Applicant: The Binding Site Group , Ltd.
Product code: Code DEH
Device class: Class 2
Regulation: 21 CFR 866.5550
Advisory panel: Immunology
Date received: 2014-02-18
Decision date: 2014-04-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

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K250159 — Immunoglobulin Isotypes (GAM) for the EXENT Analyser; EXENT Analyser2025-10-17
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Recalls naming K140396

K-number listed on FDA's recall record

Z-0274-2022 — Freelite Human Lambda Free Kit (for use on the SPAPLUS) REF LK018.S Freelite Human Lambda Free Kit (for use on the SPAPLUS) (x10) REF LK018.10SClass II·Terminated·The Binding Site Group, Ltd.·20211015

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K140396.

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