AUTOLoader, and NOVA view with models: ALDR1000, AND NV2000— 510(k) K153150

Name: FDA 510(k) clearance K153150
Creator: U.S. Food and Drug Administration
Published: 2015-11-24

Substantially Equivalent

Inova Diagnostics, Inc.

FDA 510(k) clearance K153150 for AUTOLoader, and NOVA view with models: ALDR1000, AND NV2000, Substantially Equivalent on 2015-11-24. Applicant: Inova Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Inova Diagnostics, Inc.
Product code: Code PIV
Device class: Class 2
Regulation: 21 CFR 866.4750
Advisory panel: Immunology
Date received: 2015-11-02
Decision date: 2015-11-24
Decision: Substantially Equivalent
Clearance type: Special
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

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