IMDX HSV-1/2 FOR ABBOTT M2000— 510(k) K140198

Name: FDA 510(k) clearance K140198
Creator: U.S. Food and Drug Administration
Published: 2014-05-13

Substantially Equivalent

Intelligent Medical Devices, Inc.

FDA 510(k) clearance K140198 for IMDX HSV-1/2 FOR ABBOTT M2000, Substantially Equivalent on 2014-05-13. Applicant: Intelligent Medical Devices, Inc.. Device class: 2.

Clearance details

Applicant: Intelligent Medical Devices, Inc.
Product code: Code OQO
Device class: Class 2
Regulation: 21 CFR 866.3305
Advisory panel: Microbiology
Date received: 2014-01-27
Decision date: 2014-05-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Beverly, MA, US

Download summary PDF View on FDA.gov ↗

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