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

Immunoglobulin M Kappa Heavy And Light Chain Combined

21 CFR 866.5510 / Immunology
FDA source (opens on fda.gov)

PDE is the FDA product code for Immunoglobulin M Kappa Heavy And Light Chain Combined, a class II device type, regulated under 21 CFR 866.5510. FDA's definition for this code reads: "Intended for the in-vitro quantification of IgM kappa concentration in human serum. The result is to be used with previously diagnosed igm Waldenstoms Macrolobulinaemia, in conjunction with other clinical and laboratory findings". As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
PDE
Device name
Immunoglobulin M Kappa Heavy And Light Chain Combined
FDA definition
Intended for the in-vitro quantification of IgM kappa concentration in human serum. The result is to be used with previously diagnosed igm Waldenstoms Macrolobulinaemia, in conjunction with other clinical and laboratory findings.
Regulation
21 CFR 866.5510
Device class
Class II
Review panel
Immunology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
2
Ingested recalls
0

Clearances, product code PDE

By decision year
2 clearances under product code PDE with a decision year between 2014 and 2015, 2014 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code PDE by decision year
YearClearances
20141
20151

Applicants with the most clearances

Product code PDE
Applicants holding the most 510(k) clearances under product code PDE
ApplicantClearances
The Binding Site Group Ltd.2

Companies listing this code with FDA

Companies whose registered establishments list this code