HUMAN IGA2 KIT FOR USE ON THE SPAPLUS— 510(k) K100588

Name: FDA 510(k) clearance K100588
Creator: U.S. Food and Drug Administration
Published: 2010-08-16

Substantially Equivalent

The Binding Site Group , Ltd.

FDA 510(k) clearance K100588 for HUMAN IGA2 KIT FOR USE ON THE SPAPLUS, Substantially Equivalent on 2010-08-16. Applicant: The Binding Site Group , Ltd.. Device class: 2.

Clearance details

Applicant: The Binding Site Group , Ltd.
Product code: Code CFN
Device class: Class 2
Regulation: 21 CFR 866.5510
Advisory panel: Immunology
Date received: 2010-03-02
Decision date: 2010-08-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Los Angeles, CA, US

Download summary PDF View on FDA.gov ↗

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