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

Transdermal Test For Assessment Of Glomerular Filtration Rate

Unknown
FDA source (opens on fda.gov)

SDK is the FDA product code for Transdermal Test For Assessment Of Glomerular Filtration Rate, a class III device type. FDA's definition for this code reads: "A test used to assess a patient’s glomerular filtration rate (GFR) by injecting a fluorescent tracer molecule into the blood stream and measuring the amount of fluorescence through the skin with a transdermal sensor". As of , FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code
SDK
Device name
Transdermal Test For Assessment Of Glomerular Filtration Rate
FDA definition
A test used to assess a patient’s glomerular filtration rate (GFR) by injecting a fluorescent tracer molecule into the blood stream and measuring the amount of fluorescence through the skin with a transdermal sensor.
Device class
Class III
Review panel
Unknown
Submission type
PMA
Implant
No
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