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510(k) K110435

EASYGLUCO PLUS BLOOD GLUCOSE MONITORING SYSTEM by U. S. Diagnostics, Inc. — Product Code NBW

K110435 is an FDA 510(k) premarket notification submitted by U. S. Diagnostics, Inc. for the device "EASYGLUCO PLUS BLOOD GLUCOSE MONITORING SYSTEM". The FDA issued a decision of Substantially Equivalent on September 21, 2011. The device falls under product code NBW (System, Test, Blood Glucose, Over The Counter), a Class II device regulated under 21 CFR 862.1345. U. S. Diagnostics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 21, 2011
Date Received
February 15, 2011
Clearance Type
Special
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 U. S. Diagnostics, Inc.

  • K082201 — G5 INFINITY BLODO GLUCOSE MONITORING SYSTEM WITH MODEL IGM, 0024A (February 20, 2009)
  • K061431 — EASYGLUCO, MODEL IGM-0002 G2 (January 12, 2007)
  • K051651 — G4, MODEL IGM-0004 (April 14, 2006)
  • K870685 — COAGULATION CONTROL, LEVEL I (April 20, 1987)
  • K870687 — COAGULATION CONTROL, LEVEL III (April 20, 1987)
  • K870596 — PROTHROMBIN TIME TEST (April 20, 1987)
  • K870686 — COAGULATION CONTROL, LEVEL II (April 20, 1987)
  • K871283 — CYANMETHEMOGLOBIN STANDARD (April 15, 1987)
  • K870737 — U.S. DIAGNOSTICS LIQUID LD ISOENZYME CONTROL (April 13, 1987)
  • K870738 — U.S. DIAGNOSTICS LIQUID CK ISOENZYME CONTROL (April 13, 1987)

Other clearances for product code NBW

  • 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)
  • K233058 — VivaChek Link Plus Blood Glucose Monitoring System (December 22, 2023)

FDA data resources