Human IgA liquid reagent kit for Use on SPAPlus— 510(k) K192116

Name: FDA 510(k) clearance K192116
Creator: U.S. Food and Drug Administration
Published: 2019-09-04

Substantially Equivalent

The Binding Site Group , Ltd.

FDA 510(k) clearance K192116 for Human IgA liquid reagent kit for Use on SPAPlus, Substantially Equivalent on 2019-09-04. 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: 2019-08-06
Decision date: 2019-09-04
Decision: Substantially Equivalent
Clearance type: Special
Location: Birmingham, GB

Download summary PDF View on FDA.gov ↗

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