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

System, Dialysate Delivery, Recirculating, Single Pass

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

FIJ is the FDA product code for System, Dialysate Delivery, Recirculating, Single Pass, a class II device type, regulated under 21 CFR 876.5820. As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
FIJ
Device name
System, Dialysate Delivery, Recirculating, Single Pass
Regulation
21 CFR 876.5820
Device class
Class II
Review panel
Gastroenterology, Urology
Submission type
510(k)
Implant
No
Life sustaining or supporting
Yes
GMP exempt
No
Third party review eligible
No
Ingested clearances
1
Ingested recalls
0

Clearances, product code FIJ

By decision year
1 clearance under product code FIJ with a decision year between 1977 and 1977, 1977 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code FIJ by decision year
YearClearances
19771

Applicants with the most clearances

Product code FIJ
Applicants holding the most 510(k) clearances under product code FIJ
ApplicantClearances
Extracorporeal Medical Specialities, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code FIJ.