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

Indicator, Biological, Liquid Chemical Sterilization Process

21 CFR 880.2800 / General Hospital
FDA source (opens on fda.gov)

MRB is the FDA product code for Indicator, Biological, Liquid Chemical Sterilization Process, a class II device type, regulated under 21 CFR 880.2800. As of , FDA records hold 4 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
MRB
Device name
Indicator, Biological, Liquid Chemical Sterilization Process
Regulation
21 CFR 880.2800
Device class
Class II
Review panel
General Hospital
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
4
Ingested recalls
0

Clearances, product code MRB

By decision year
4 clearances under product code MRB with a decision year between 2004 and 2008, 2004 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code MRB by decision year
YearClearances
20041
20051
20061
20081

Applicants with the most clearances

Product code MRB
Applicants holding the most 510(k) clearances under product code MRB
ApplicantClearances
Raven Biological Laboratories, Inc.2
Spsmedical Supply Corp.2

Companies listing this code with FDA

Companies whose registered establishments list this code