Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

SMART READ EZTEST STEAM

K-Number: K112018 · 2012-01-30

ApplicantMesa Laboratories, Inc.
Decision Date2012-01-30
Product CodeFRC
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SMART READ EZTEST STEAM is the device name listed in this FDA 510(k) record. The listed applicant is Mesa Laboratories, Inc.. It received FDA 510(k) clearance on 2012-01-30 under 510(k) number K112018. The device is classified under product code FRC. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SMART READ EZTEST STEAM?

SMART READ EZTEST STEAM is a medical device that received FDA 510(k) clearance on 2012-01-30. The listed applicant is Mesa Laboratories, Inc.. The 510(k) number is K112018.

When did SMART READ EZTEST STEAM receive FDA 510(k) clearance?

SMART READ EZTEST STEAM received FDA 510(k) clearance on 2012-01-30, under 510(k) number K112018.

Who is the listed applicant for SMART READ EZTEST STEAM?

The FDA 510(k) record lists Mesa Laboratories, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SMART READ EZTEST STEAM?

The FDA product code for SMART READ EZTEST STEAM is FRC.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Mesa Laboratories, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K201765SmartHDM-510 SystemK191496TDS Standard SolutionK130100COMINED STANDARD SOLUTIONK122362SMART-WELL INCUBATORK05081290XL INSTRUMENTATION SYSTEMK033330CONDUCTIVITY/TDS CALIBRATOR SOLUTION

View all 7 devices →

Related Devices (Code: FRC)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260766Celerity 5 HP Biological Indicator (LCB052)STERIS CorporationK252680Celerity™ 20 HP Biological IndicatorSTERIS CorporationK251122Terragene® Bionova® BT20 Biological IndicatorTerrageneK251452Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059); Celerity 20 HP Biological Indicator (LCB044); Celerity 20 HP Challenge Pack (LCB045)SterisK250044Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059); Celerity 20 HP Biological Indicator (LCB044); Celerity 20 HP Challenge Pack (LCB045)STERIS CorporationK250061Celerity IncubatorSTERIS Corporation

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑