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

System, Test, Immunological, Antigen, Tumor

21 CFR 866.6010 / Immunology
FDA source (opens on fda.gov)

MOI is the FDA product code for System, Test, Immunological, Antigen, Tumor, a class II device type, regulated under 21 CFR 866.6010. As of , FDA records hold 28 510(k) clearances under this code, the most recent dated , and 18 recalls.

Classification record

Product code
MOI
Device name
System, Test, Immunological, Antigen, Tumor
Regulation
21 CFR 866.6010
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
28
Ingested recalls
18

Clearances, product code MOI

By decision year
28 clearances under product code MOI with a decision year between 1997 and 2024, 1997 the highest year at 7.
Show the numbers
510(k) clearances under FDA product code MOI by decision year
YearClearances
19977
19983
19991
20001
20012
20023
20042
20071
20111
20182
20191
20202
20242

Applicants with the most clearances

Product code MOI
Applicants holding the most 510(k) clearances under product code MOI
ApplicantClearances
Siemens Healthcare Diagnostics Inc.7
Roche Diagnostics GmbH4
Chiron Diagnostics Corp.3
Abbott Medical2
Bayer Diagnostics Corp.2
Chiron Corp.2
Fujirebio Diagnostics, Inc.2
Bayer Corp.1
Biomira USA, Inc.1
Centocor, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 16 companies shown, in name order