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

Antigen, Elisa, Cryptococcus

21 CFR 866.3165 / Microbiology
FDA source (opens on fda.gov)

MDU is the FDA product code for Antigen, Elisa, Cryptococcus, a class II device type, regulated under 21 CFR 866.3165. As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
MDU
Device name
Antigen, Elisa, Cryptococcus
Regulation
21 CFR 866.3165
Device class
Class II
Review panel
Microbiology
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
2
Ingested recalls
1

Clearances, product code MDU

By decision year
2 clearances under product code MDU with a decision year between 1991 and 2012, 1991 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code MDU by decision year
YearClearances
19911
20121

Applicants with the most clearances

Product code MDU
Applicants holding the most 510(k) clearances under product code MDU
ApplicantClearances
IMMY, Inc.1
Meridian Diagnostics, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code