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

Eia, Blastomyces Dermatitidis

21 CFR 866.3060 / Microbiology
FDA source (opens on fda.gov)

MJL is the FDA product code for Eia, Blastomyces Dermatitidis, a class II device type, regulated under 21 CFR 866.3060. As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
MJL
Device name
Eia, Blastomyces Dermatitidis
Regulation
21 CFR 866.3060
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
0

Clearances, product code MJL

By decision year
2 clearances under product code MJL with a decision year between 1984 and 1992, 1984 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code MJL by decision year
YearClearances
19841
19921

Applicants with the most clearances

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

Companies listing this code with FDA

Companies whose registered establishments list this code