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

Culture Media, Antifungal, Susceptibility Test

21 CFR 866.1700 / Microbiology
FDA source (opens on fda.gov)

MJE is the FDA product code for Culture Media, Antifungal, Susceptibility Test, a class II device type, regulated under 21 CFR 866.1700. As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
MJE
Device name
Culture Media, Antifungal, Susceptibility Test
Regulation
21 CFR 866.1700
Device class
Class II
Review panel
Microbiology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
1
Ingested recalls
0

Clearances, product code MJE

By decision year
1 clearance under product code MJE with a decision year between 2007 and 2007, 2007 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code MJE by decision year
YearClearances
20071

Applicants with the most clearances

Product code MJE
Applicants holding the most 510(k) clearances under product code MJE
ApplicantClearances
Remel Inc1

Companies listing this code with FDA

Companies whose registered establishments list this code