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

Fungal Organisms, Nucleic Acid-Based Assay

21 CFR 866.3365 / Microbiology
FDA source (opens on fda.gov)

PEO is the FDA product code for Fungal Organisms, Nucleic Acid-Based Assay, a class II device type, regulated under 21 CFR 866.3365. FDA's definition for this code reads: "A qualitative multiplexed in vitro diagnostic device to detect and identify fungal organisms in positive blood cultures". As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
PEO
Device name
Fungal Organisms, Nucleic Acid-Based Assay
FDA definition
A qualitative multiplexed in vitro diagnostic device to detect and identify fungal organisms in positive blood cultures.
Regulation
21 CFR 866.3365
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
2
Ingested recalls
0

Clearances, product code PEO

By decision year
2 clearances under product code PEO with a decision year between 2018 and 2024, 2018 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code PEO by decision year
YearClearances
20181
20241

Applicants with the most clearances

Product code PEO
Applicants holding the most 510(k) clearances under product code PEO
ApplicantClearances
Genmark Diagnostics, Incorporated1
Luminex Corporation1

Companies listing this code with FDA

Companies whose registered establishments list this code