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

Detector, Leak, Blood

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

FJD is the FDA product code for Detector, Leak, Blood, a class II device type, regulated under 21 CFR 876.5820. As of , FDA records hold 4 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
FJD
Device name
Detector, Leak, Blood
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
4
Ingested recalls
0

Clearances, product code FJD

By decision year
4 clearances under product code FJD with a decision year between 1999 and 2013, 1999 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code FJD by decision year
YearClearances
19991
20011
20041
20131

Applicants with the most clearances

Product code FJD
Applicants holding the most 510(k) clearances under product code FJD
ApplicantClearances
Serim Research Corp.2
Hach Company1
Reprocessing Products Corp1

Companies listing this code with FDA

Companies whose registered establishments list this code