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Elect Blood Glucose Monitorig System

by Selfcare, Inc.

510(k) K961985

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK961985 Date5 Sep 1996ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
CGA
Device Class
Class II
Regulation
21 CFR Part 862.1345
Advisory Committee
Clinical Chemistry
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 27 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Elect Blood Glucose Monitoring System is a device used for measuring blood glucose levels. It operates by measuring electrical current generated by glucose oxidation, where the current is proportional to glucose concentration. The system is calibrated to plasma-equivalent values and displays results in 15 seconds.

This device is intended for use by diabetics at home for self-monitoring of blood glucose levels to aid in diabetes management. It is supplied as a complete system and is authorized under FDA 510(k) clearance number K961985. The device is classified under product code CGA and regulation number 862.1345.

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