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510(k) K160282

SD LipidoCare Professional System, SD LipidoCare Home System, SD LipidoCare BT Professional System, SD LipidoCare BT Home System by Sd Biosensor — Product Code NBW

K160282 is an FDA 510(k) premarket notification submitted by Sd Biosensor for the device "SD LipidoCare Professional System, SD LipidoCare Home System, SD LipidoCare BT Professional System, SD LipidoCare BT Home System". The FDA issued a decision of Substantially Equivalent on October 17, 2017. The device falls under product code NBW (System, Test, Blood Glucose, Over The Counter), a Class II device regulated under 21 CFR 862.1345. Sd Biosensor has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 17, 2017
Date Received
February 2, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Test, Blood Glucose, Over The Counter
Device Class
Class II
Regulation Number
862.1345
Review Panel
CH
Submission Type

Other clearances by Sd Biosensor

  • K153201 — SD GlucoNavii Mentor BT Blood Glucose Monitoring System, SD GlucoNavii Mentor BT (June 24, 2016)
  • K151265 — SD GlucoNFC Blood Glucose Monitoring System, SD GlucoNFC Multi Blood Glucose Mon (November 24, 2015)
  • K140827 — SD A1cCare System, SD A1cCare Spoit Type Test Kit, SD HbA1c Control Set (September 30, 2015)
  • K132929 — SD GLUCONAVII MENTOR NFC MULTI BLOOD GLUCOSE MONITORING SYSTEM, AND SD GLUCONAVI (August 5, 2015)
  • K123517 — GLUCOMENTOR BLOOD GLUCOSE MONITORING SYSTEM, GLUCOMENTOR MULTI BLOOD GLUCOSE MON (January 17, 2014)

Other clearances for product code NBW

  • K262116 — TRUE METRIX Self Monitoring Blood Glucose System (July 23, 2026)
  • K250085 — On Call® Sure GK Blood Glucose & Ketone Monitoring System; On Call® Sure Sync GK (October 10, 2025)
  • K243060 — TeleRPM Gen2 Blood Glucose Monitoring System (January 30, 2025)
  • K240637 — RIGHTEST Blood Glucose Monitoring System Max Tel (November 4, 2024)
  • K240640 — Sejoy Blood Glucose Monitoring System; Sejoy Advance Link Blood Glucose Monitori (October 8, 2024)
  • K241787 — CONTOUR® PLUS BLUE Blood Glucose Monitoring System; CONTOUR® NEXT GEN Blood Gluc (August 27, 2024)
  • K222126 — VivaChek™ Fad Blood Glucose Monitoring System, VivaChek™ Fad Smart Blood Glucose (August 16, 2024)
  • K241304 — WaveSense Jazz Blood Glucose Monitoring System (June 6, 2024)
  • K231679 — CONTOUR® PLUS BLUE Blood Glucose Monitoring System (February 23, 2024)
  • K231192 — RIGHTEST Blood Glucose Monitoring System Max Tel (January 19, 2024)

FDA data resources