Fenom Pro— 510(k) K213611

Substantially Equivalent

Caire Diagnostics, Inc.

FDA 510(k) clearance K213611 for Fenom Pro, Substantially Equivalent on 2023-06-07. Applicant: Caire Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Caire Diagnostics, Inc.
Product code: Code MXA
Device class: Class 2
Regulation: 21 CFR 862.3080
Advisory panel: Clinical Toxicology
Date received: 2021-11-15
Decision date: 2023-06-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pleasanton, CA, 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.