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

Antibodies, Gliadin

21 CFR 866.5750 / Immunology
FDA source (opens on fda.gov)

MST is the FDA product code for Antibodies, Gliadin, a class II device type, regulated under 21 CFR 866.5750. As of , FDA records hold 42 510(k) clearances under this code, the most recent dated , and 3 recalls.

Classification record

Product code
MST
Device name
Antibodies, Gliadin
Regulation
21 CFR 866.5750
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
42
Ingested recalls
3

Clearances, product code MST

By decision year
42 clearances under product code MST with a decision year between 1997 and 2017, 1999 the highest year at 6.
Show the numbers
510(k) clearances under FDA product code MST by decision year
YearClearances
19974
19984
19996
20005
20012
20043
20052
20064
20072
20081
20092
20102
20111
20122
20131
20171

Applicants with the most clearances

Product code MST
Applicants holding the most 510(k) clearances under product code MST
ApplicantClearances
Inova Diagnostics, Inc.8
Immco Diagnostics, Inc.4
Zeus Scientific LLC4
The Binding Site3
Aesku Diagnostics2
Cogent Diagnotics, Ltd.2
Diamedix Corp.2
Euroimmun US Inc.2
Micro Detect, Inc.2
Phadia AB2

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 16 companies shown, in name order