510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
LRIClass II

Ph Meter For Dialysis Hydrogen Ion Concentration

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

LRI is the FDA product code for Ph Meter For Dialysis Hydrogen Ion Concentration, 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
LRI
Device name
Ph Meter For Dialysis Hydrogen Ion Concentration
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 LRI

By decision year
1 clearance under product code LRI with a decision year between 1987 and 1987, 1987 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code LRI by decision year
YearClearances
19871

Applicants with the most clearances

Product code LRI
Applicants holding the most 510(k) clearances under product code LRI
ApplicantClearances
Mesa Medical, 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 LRI.