510(k) clearances

Access MeMed BV

Beckman Coulter, Inc. · Microbiology

K261109Substantially EquivalentTraditionalQPS
Open FDA's page for this record
Third party flag
N
City
Chaska
Advisory committee description
Microbiology
Address 1
1000 Lake Hazeltine Dr.
Statement or summary
Summary
Product code
QPS
Zip code
55318
Applicant
Beckman Coulter, Inc.
Decision date
2026-10-19
Decision code
SESE
Country code
US
Device name
Access MeMed BV
Advisory committee
MI
Contact
Christopher Fulmer
K number
K261109
State
MN
Date received
2026-04-03
Review advisory committee
MI
Postal code
55318
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Immunoassay For Host Biomarkers Of Infection
Medical specialty description
Microbiology
Regulation number
866.3215
Device class
2
Registration number
2182595, 3006165521, 3011096386, 3005269352
FEI number
2182595, 3006165521, 3011096386, 3005269352
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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.