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

Susceptibility Test Powders, Antimycobacterial

21 CFR 866.1640 / Microbiology
FDA source (opens on fda.gov)

MJA is the FDA product code for Susceptibility Test Powders, Antimycobacterial, a class II device type, regulated under 21 CFR 866.1640. As of , FDA records hold 5 510(k) clearances under this code, the most recent dated , and 6 recalls.

Classification record

Product code
MJA
Device name
Susceptibility Test Powders, Antimycobacterial
Regulation
21 CFR 866.1640
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
No
Ingested clearances
5
Ingested recalls
6

Clearances, product code MJA

By decision year
5 clearances under product code MJA with a decision year between 1999 and 2006, 2002 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code MJA by decision year
YearClearances
19991
20011
20022
20061

Applicants with the most clearances

Product code MJA
Applicants holding the most 510(k) clearances under product code MJA
ApplicantClearances
Becton Dickinson & Co2
Trek Diagnostic Systems, Ltd.2
BD Becton Dickinson Vacutainer Systems Preanalytic1

Companies listing this code with FDA

Companies whose registered establishments list this code