510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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QBJClass II

Integrated Continuous Glucose Monitoring System, Factory Calibrated

21 CFR 862.1355 / Clinical Chemistry
FDA source (opens on fda.gov)

QBJ is the FDA product code for Integrated Continuous Glucose Monitoring System, Factory Calibrated, a class II device type, regulated under 21 CFR 862.1355. FDA's definition for this code reads: "An integrated continuous glucose monitoring system (iCGM) is intended to automatically measure glucose in bodily fluids continuously or frequently for a specified period of time. iCGM systems are designed to reliably and securely transmit glucose measurement data to digitally connected devices, including automated...". As of , FDA records hold 18 510(k) clearances under this code, the most recent dated , and 23 recalls.

Classification record

Product code
QBJ
Device name
Integrated Continuous Glucose Monitoring System, Factory Calibrated
FDA definition
An integrated continuous glucose monitoring system (iCGM) is intended to automatically measure glucose in bodily fluids continuously or frequently for a specified period of time. iCGM systems are designed to reliably and securely transmit glucose measurement data to digitally connected devices, including automated insulin dosing systems, and are intended to be used alone or in conjunction with these digitally connected medical devices for the purpose of managing a disease or condition related to glycemic control.
Regulation
21 CFR 862.1355
Device class
Class II
Review panel
Clinical Chemistry
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
18
Ingested recalls
23

Clearances, product code QBJ

By decision year
18 clearances under product code QBJ with a decision year between 2018 and 2026, 2023 the highest year at 4.
Show the numbers
510(k) clearances under FDA product code QBJ by decision year
YearClearances
20181
20192
20201
20211
20222
20234
20243
20252
20262

Applicants with the most clearances

Product code QBJ
Applicants holding the most 510(k) clearances under product code QBJ
ApplicantClearances
Dexcom, Inc.15
Abbott Medical3

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 27 companies shown, in name order