510(k) clearances

Alinity m BKV

Abbott Molecular, Inc. · Microbiology

K241921Substantially EquivalentTraditionalQMI
Open FDA's page for this record
Third party flag
N
City
Des Plaines
Advisory committee description
Microbiology
Address 1
1300 E Touhy Ave.
Statement or summary
Summary
Product code
QMI
Zip code
60018
Applicant
Abbott Molecular, Inc.
Decision date
2025-03-24
Decision code
SESE
Country code
US
Device name
Alinity m BKV
Advisory committee
MI
Contact
Gina Sammarco
K number
K241921
State
IL
Date received
2024-07-01
Review advisory committee
MI
Postal code
60018
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Nucleic Acid Amplification Test For The Quantitation Of Bk Virus (Bk) Dna
Medical specialty description
Microbiology
Regulation number
866.3183
Device class
2
Registration number
3003795116, 2243471, 3019837962, 3005248192, 3004141078
FEI number
3003795116, 2243471, 3019837962, 3005248192, 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.