ROM PLUS— 510(k) K110605

Substantially Equivalent

Clinical Innovations, LLC

FDA 510(k) clearance K110605 for ROM PLUS, Substantially Equivalent on 2011-11-23. Applicant: Clinical Innovations, LLC. Device class: 1.

Clearance details

Applicant: Clinical Innovations, LLC
Product code: Code NQM
Device class: Class 1
Regulation: 21 CFR 862.1550
Advisory panel: Clinical Chemistry
Date received: 2011-03-02
Decision date: 2011-11-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Murray, UT, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K110605

K-number listed on FDA's recall record

Z-0541-2021 — Clinical Innovations ROM Plus Collection Kit IFU: ROM Plus Rupture of Membrane Test ROM-5025, ROM-6025Class II·Terminated·Clinical Innovations, LLC·20200813

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K110605.

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