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

Devices, Measure, Antibodies To Glomerular Basement Membrane (Gbm)

21 CFR 866.5660 / Immunology
FDA source (opens on fda.gov)

MVJ is the FDA product code for Devices, Measure, Antibodies To Glomerular Basement Membrane (Gbm), a class II device type, regulated under 21 CFR 866.5660. As of , FDA records hold 6 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
MVJ
Device name
Devices, Measure, Antibodies To Glomerular Basement Membrane (Gbm)
Regulation
21 CFR 866.5660
Device class
Class II
Review panel
Immunology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
6
Ingested recalls
0

Clearances, product code MVJ

By decision year
6 clearances under product code MVJ with a decision year between 1999 and 2007, 1999 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code MVJ by decision year
YearClearances
19993
20011
20072

Applicants with the most clearances

Product code MVJ
Applicants holding the most 510(k) clearances under product code MVJ
ApplicantClearances
Bio-Rad Laboratories Inc.1
Cogent Diagnotics, Ltd.1
Inova Diagnostics, Inc.1
Scimedx Corp.1
The Binding Site1
Zeus Scientific LLC1

Companies listing this code with FDA

Companies whose registered establishments list this code