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

Solution-Test Standard-Conductivity, Dialysis

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

FKH is the FDA product code for Solution-Test Standard-Conductivity, Dialysis, a class II device type, regulated under 21 CFR 876.5820. As of , FDA records hold 8 510(k) clearances under this code, the most recent dated , and 2 recalls.

Classification record

Product code
FKH
Device name
Solution-Test Standard-Conductivity, Dialysis
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
Yes
Ingested clearances
8
Ingested recalls
2

Clearances, product code FKH

By decision year
8 clearances under product code FKH with a decision year between 1981 and 2019, 2004 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code FKH by decision year
YearClearances
19811
19851
19861
20031
20042
20131
20191

Applicants with the most clearances

Product code FKH
Applicants holding the most 510(k) clearances under product code FKH
ApplicantClearances
Mesa Laboratories Inc3
Amisco Trading Corp.1
D.R.G. Scientific Industries1
H & S Technical Services1
Ibp Instruments GmbH1
Rna Medical Corp.1

Companies listing this code with FDA

Companies whose registered establishments list this code