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

Continuous Glucose Monitor, Implanted, Adjunctive Use

Unknown
FDA source (opens on fda.gov)

QCD is the FDA product code for Continuous Glucose Monitor, Implanted, Adjunctive Use, a class III device type. FDA's definition for this code reads: "The device is a fully implanted continuous glucose monitoring device intended to detect trends and track patterns in interstitial glucose values. The device is indicated for use as an adjunctive device to complement, not replace, information obtained from standard home blood glucose monitoring devices". As of , FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code
QCD
Device name
Continuous Glucose Monitor, Implanted, Adjunctive Use
FDA definition
The device is a fully implanted continuous glucose monitoring device intended to detect trends and track patterns in interstitial glucose values. The device is indicated for use as an adjunctive device to complement, not replace, information obtained from standard home blood glucose monitoring devices.
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
0

Companies listing this code with FDA

Companies whose registered establishments list this code