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

Test System, Antineutrophil Cytoplasmic Antibodies (Anca)

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

MOB is the FDA product code for Test System, Antineutrophil Cytoplasmic Antibodies (Anca), a class II device type, regulated under 21 CFR 866.5660. As of , FDA records hold 75 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
MOB
Device name
Test System, Antineutrophil Cytoplasmic Antibodies (Anca)
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
75
Ingested recalls
1

Clearances, product code MOB

By decision year
75 clearances under product code MOB with a decision year between 1995 and 2026, 1998 the highest year at 17.
Show the numbers
510(k) clearances under FDA product code MOB by decision year
YearClearances
19952
199610
19979
199817
19992
20002
20014
20045
20053
20064
20071
20092
20106
20121
20141
20171
20183
20251
20261

Applicants with the most clearances

Product code MOB
Applicants holding the most 510(k) clearances under product code MOB
ApplicantClearances
Inova Diagnostics, Inc.8
Zeus Scientific LLC8
Euroimmun US Inc.5
Scimedx Corp.5
Immco Diagnostics, Inc.4
IMMUNO CONCEPTS, NA, Ltd.4
The Binding Site4
Wieslab AB4
Biomedical Diagnostics (Bmd) SA3
Hemagen Diagnostics, Inc.3

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 22 companies shown, in name order