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

Flow Cytometry Calibrator

21 CFR 864.5220 / Hematology
FDA source (opens on fda.gov)

PDX is the FDA product code for Flow Cytometry Calibrator, a class II device type, regulated under 21 CFR 864.5220. FDA's definition for this code reads: "Flow cytometer calibrators are polystyrene or other particles whose defined characteristics (e.g. number, size, scatter or fluorescence intensity) is used to standardize instrumentation or to quantify other particles or analytes measured by flow cytometers". As of , FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code
PDX
Device name
Flow Cytometry Calibrator
FDA definition
Flow cytometer calibrators are polystyrene or other particles whose defined characteristics (e.g. number, size, scatter or fluorescence intensity) is used to standardize instrumentation or to quantify other particles or analytes measured by flow cytometers.
Regulation
21 CFR 864.5220
Device class
Class II
Review panel
Hematology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
0
Ingested recalls
0

Companies listing this code with FDA

Companies whose registered establishments list this code