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

Disinfectant, Dialysate Delivery System

21 CFR 876.5860 / Gastroenterology, Urology
FDA source (opens on fda.gov)

NII is the FDA product code for Disinfectant, Dialysate Delivery System, a class II device type, regulated under 21 CFR 876.5860. FDA's definition for this code reads: "Disinfectant intended for reprocessing dialysate delivery systems". As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
NII
Device name
Disinfectant, Dialysate Delivery System
FDA definition
Disinfectant intended for reprocessing dialysate delivery systems.
Regulation
21 CFR 876.5860
Device class
Class II
Review panel
Gastroenterology, Urology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
2
Ingested recalls
0

Clearances, product code NII

By decision year
2 clearances under product code NII with a decision year between 2004 and 2005, 2004 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code NII by decision year
YearClearances
20041
20051

Applicants with the most clearances

Product code NII
Applicants holding the most 510(k) clearances under product code NII
ApplicantClearances
GE Infrastructure Water & Process Technologies1
Krd Co., Ltd.1

Companies listing this code with FDA

Companies whose registered establishments list this code