RNA Medical Tonometer

No FDA recalls on record, checked 11 Oct 2026.

510(k) Number

K922386 ↗

FDA Product Code

LCH

Device Class

Class I

Regulation

21 CFR Part 862.1660

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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  FDA 510(k) K022769 Active Cleared 13 Nov 2002

• RNA Medical Glucose and B-Ketone Calibration Verification Controls

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  FDA 510(k) K081478 Active Cleared 6 Oct 2008

• RNA1C Control for Nycocard HBA1C

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  FDA 510(k) K050961 Active Cleared 13 May 2005

• Flush Solution Concentrate-Blood Gas

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• Glucose Meter-Check Control for Nipro Trueresult

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  FDA 510(k) K112352 Active Cleared 23 Dec 2011

• Combitrol Ts Multi Analyte Control, Levels 1, 2, 3, Autotrol Ts Multi Analyte Control, Levels 1, 2, 3

  Class I

  FDA 510(k) K012431 Active Cleared 28 Aug 2001

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