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

Detector, Dialysate Level

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

FJB is the FDA product code for Detector, Dialysate Level, a class II device type, regulated under 21 CFR 876.5820. As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
FJB
Device name
Detector, Dialysate Level
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
3
Ingested recalls
0

Clearances, product code FJB

By decision year
3 clearances under product code FJB with a decision year between 1988 and 1988, 1988 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code FJB by decision year
YearClearances
19883

Applicants with the most clearances

Product code FJB
Applicants holding the most 510(k) clearances under product code FJB
ApplicantClearances
Cobe Laboratories, Inc.1
National Medical Care, Medical Products Div., Inc.1
Yankee Intl. Medical Research & Mfg., Ltd.1

Companies listing this code with FDA

Companies whose registered establishments list this code

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