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510(k) K133003

RIGHTEST CONTROL SOLUTION by Bionime Corporation — Product Code JJX

K133003 is an FDA 510(k) premarket notification submitted by Bionime Corporation for the device "RIGHTEST CONTROL SOLUTION". The FDA issued a decision of Substantially Equivalent on October 24, 2013. The device falls under product code JJX (Single (Specified) Analyte Controls (Assayed And Unassayed)), a Class I device regulated under 21 CFR 862.1660. Bionime Corporation has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 24, 2013
Date Received
September 25, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Single (Specified) Analyte Controls (Assayed And Unassayed)
Device Class
Class I
Regulation Number
862.1660
Review Panel
CH
Submission Type

Other clearances by Bionime Corporation

  • K240637 — RIGHTEST Blood Glucose Monitoring System Max Tel (November 4, 2024)
  • K231192 — RIGHTEST Blood Glucose Monitoring System Max Tel (January 19, 2024)
  • K221062 — RIGHTEST Lancing Device GD500, GE Lancing Device, iGlucose Lancing Device (September 26, 2022)
  • K190564 — Rightest Blood Glucose Monitoring System GM700S, Rightest Blood Glucose Monitori (June 2, 2019)
  • K173638 — Rightest Blood Glucose Monitoring System Max, Rightest Blood Glucose Monitoring (August 17, 2018)
  • K173139 — Rightest Blood Glucose Monitoring System Wiz, Rightest Blood Glucose Monitoring (June 19, 2018)
  • K170143 — GE Blood Glucose Monitoring System 180, GE Blood Glucose Monitoring System 182, (July 6, 2017)
  • K161790 — iGlucose Blood Glucose Monitoring System (May 2, 2017)
  • K140210 — RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM ( GM720, RIGHTEST PROFESSIONAL BGMS GM7 (August 22, 2014)
  • K123008 — RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM GM700 GE GE200 BLOOD GLUCOSE MONITORING (January 25, 2013)

Other clearances for product code JJX

  • K170678 — Beta-CrossLaps CalCheck 5 (April 4, 2017)
  • K162173 — Elecsys CYFRA 21-1 CalCheck 5 (January 12, 2017)
  • K162514 — Multichem A1c (October 26, 2016)
  • K161874 — Audit MicroControls Linearity DROP LQ Blood Glucose (August 10, 2016)
  • K161526 — LIAISON CMV IgM Serum Control Set (June 30, 2016)
  • K161522 — LIAISON EBV IgM Serum Control Set (June 30, 2016)
  • K161082 — IDS-iSYS 17-OH Progesterone Control Set, IDS-iSYS 17-OH Progesterone Calibration (May 17, 2016)
  • K152117 — Dropper hsCRP High Sensitivity CRP Control (April 21, 2016)
  • K151742 — Contour Next Control Solution (September 23, 2015)
  • K143687 — ADVIA Centaur Follicle Stimulating Hormone (FSH) Master Curve Material, ADVIA Ce (July 17, 2015)

FDA data resources