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

Detector, Blood Level

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

FJC is the FDA product code for Detector, Blood Level, 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
FJC
Device name
Detector, Blood 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
1
Ingested recalls
0

Clearances, product code FJC

By decision year
1 clearance under product code FJC with a decision year between 1995 and 1995, 1995 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code FJC by decision year
YearClearances
19951

Applicants with the most clearances

Product code FJC
Applicants holding the most 510(k) clearances under product code FJC
ApplicantClearances
Welch Allyn Inc1

Companies listing this code with FDA

Companies whose registered establishments list this code

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