Free Testosterone AccuBind ELISA Test System— 510(k) K181017

Name: FDA 510(k) clearance K181017
Creator: U.S. Food and Drug Administration
Published: 2018-07-20

Substantially Equivalent

Monobind, Inc.

FDA 510(k) clearance K181017 for Free Testosterone AccuBind ELISA Test System, Substantially Equivalent on 2018-07-20. Applicant: Monobind, Inc.. Device class: 1.

Clearance details

Applicant: Monobind, Inc.
Product code: Code CDZ
Device class: Class 1
Regulation: 21 CFR 862.1680
Advisory panel: Clinical Chemistry
Date received: 2018-04-10
Decision date: 2018-07-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lake Forest, CA, US

Download summary PDF View on FDA.gov ↗

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