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PCOClass II

Immunoglobulin G Lambda Heavy And Light Chain Combined

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

PCO is the FDA product code for Immunoglobulin G Lambda 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 IgG lambda concentration in human serum. The result is to be used with previously diagnosed IgG multiple myeloma, in conjunction with other clinical and laboratory findings". As of , FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code
PCO
Device name
Immunoglobulin G Lambda Heavy And Light Chain Combined
FDA definition
Intended for the in-vitro quantification of IgG lambda concentration in human serum. The result is to be used with previously diagnosed IgG multiple myeloma, 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
0
Ingested recalls
0

Companies listing this code with FDA

Companies whose registered establishments list this code