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

Dna-Probe, Reagent, Histoplasma Capsulatum

21 CFR 866.3320 / Microbiology
FDA source (opens on fda.gov)

MBT is the FDA product code for Dna-Probe, Reagent, Histoplasma Capsulatum, a class II device type, regulated under 21 CFR 866.3320. As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
MBT
Device name
Dna-Probe, Reagent, Histoplasma Capsulatum
Regulation
21 CFR 866.3320
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
1
Ingested recalls
0

Clearances, product code MBT

By decision year
1 clearance under product code MBT with a decision year between 1990 and 1990, 1990 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code MBT by decision year
YearClearances
19901

Applicants with the most clearances

Product code MBT
Applicants holding the most 510(k) clearances under product code MBT
ApplicantClearances
Hologic, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code MBT.