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

Sensor, Glucose, Implanted, Non-Adjunctive Use

Unknown
FDA source (opens on fda.gov)

QHJ is the FDA product code for Sensor, Glucose, Implanted, Non-Adjunctive Use, a class III device type. FDA's definition for this code reads: "A non-adjunctive implanted glucose sensor is intended to determine glucose levels, and the direction and rate of change of glucose levels in people with diabetes. The device is indicated to replace information obtained from standard blood glucose monitoring devices to make diabetes-related treatment decisions. The...". As of , FDA records hold no 510(k) clearances under this code and one recall.

Classification record

Product code
QHJ
Device name
Sensor, Glucose, Implanted, Non-Adjunctive Use
FDA definition
A non-adjunctive implanted glucose sensor is intended to determine glucose levels, and the direction and rate of change of glucose levels in people with diabetes. The device is indicated to replace information obtained from standard blood glucose monitoring devices to make diabetes-related treatment decisions. The device also provides historical glucose information, facilitating long-term therapy adjustments.
Device class
Class III
Review panel
Unknown
Submission type
PMA
Implant
Yes
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
0
Ingested recalls
1

Companies listing this code with FDA

Companies whose registered establishments list this code