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

System, Blood, Extracorporeal And Accessories

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

LLB is the FDA product code for System, Blood, Extracorporeal And Accessories, a class II device type, regulated under 21 CFR 876.5820. As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
LLB
Device name
System, Blood, Extracorporeal And Accessories
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
2
Ingested recalls
1

Clearances, product code LLB

By decision year
2 clearances under product code LLB with a decision year between 1984 and 1999, 1984 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code LLB by decision year
YearClearances
19841
19991

Applicants with the most clearances

Product code LLB
Applicants holding the most 510(k) clearances under product code LLB
ApplicantClearances
Dayspring Medical, Inc.1
Gambro, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code