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

Test, Vaginal, Bacterial Sialidase

21 CFR 866.2660 / Microbiology
FDA source (opens on fda.gov)

MXB is the FDA product code for Test, Vaginal, Bacterial Sialidase, a class I device type, regulated under 21 CFR 866.2660. As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
MXB
Device name
Test, Vaginal, Bacterial Sialidase
Regulation
21 CFR 866.2660
Device class
Class I
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 MXB

By decision year
2 clearances under product code MXB with a decision year between 2000 and 2005, 2000 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code MXB by decision year
YearClearances
20001
20051

Applicants with the most clearances

Product code MXB
Applicants holding the most 510(k) clearances under product code MXB
ApplicantClearances
Gryphus Diagnostics, L.L.C.2

Companies listing this code with FDA

Companies whose registered establishments list this code