510(k) clearances

BIOFIRE SPOTFIRE Vaginitis (VG) Panel

Biofire Diagnostics, LLC · Microbiology

K262136Substantially EquivalentDual TrackPQA
Open FDA's page for this record
Third party flag
N
City
Salt Lake City
Advisory committee description
Microbiology
Address 1
515 Colorow Dr.
Statement or summary
Summary
Product code
PQA
Zip code
84108
Applicant
Biofire Diagnostics, LLC
Decision date
2026-10-21
Decision code
SESE
Country code
US
Device name
BIOFIRE SPOTFIRE Vaginitis (VG) Panel
Advisory committee
MI
Contact
Erin Moseley
K number
K262136
State
UT
Date received
2026-06-25
Review advisory committee
MI
Postal code
84108
Decision description
Substantially Equivalent
Clearance type
Dual Track
Harmonized identifiers (openFDA)
Device name
Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System
Medical specialty description
Microbiology
Regulation number
866.3975
Device class
2
Registration number
3004530258, 2024800, 3007420875, 2243471, 3016838963, 1119779, 3002444944, 3004141078
FEI number
3004530258, 2024800, 3007420875, 2243471, 3016838963, 1119779, 3002444944, 3004141078
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.