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

Dialyzer Reprocessing System

21 CFR 876.5820 / Gastroenterology, Urology
FDA source (opens on fda.gov)

LIF is the FDA product code for Dialyzer Reprocessing System, a class II device type, regulated under 21 CFR 876.5820. As of , FDA records hold 57 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
LIF
Device name
Dialyzer Reprocessing System
Regulation
21 CFR 876.5820
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
57
Ingested recalls
1

Clearances, product code LIF

By decision year
57 clearances under product code LIF with a decision year between 1981 and 2010, 1983 the highest year at 7.
Show the numbers
510(k) clearances under FDA product code LIF by decision year
YearClearances
19812
19825
19837
19846
19854
19862
19873
19882
19902
19914
19922
19941
19952
19964
19971
19981
19992
20001
20021
20031
20042
20051
20101

Applicants with the most clearances

Product code LIF
Applicants holding the most 510(k) clearances under product code LIF
ApplicantClearances
Seratronics, Inc.9
Renal Systems, Inc.6
Serim Research Corp.5
Colorado Medical, Inc.4
Computer Dialysis Systems, Inc.3
Mesa Medical, Inc.3
Medivators Inc3
Medicorp, Inc.2
Alcavis International Incorporated1
Alcavis International, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code