510(k) clearances

Access BR Monitor

Beckman Coulter, Inc. · Immunology

K240403Substantially EquivalentTraditionalMOI
Open FDA's page for this record
Third party flag
N
City
Chaska
Advisory committee description
Immunology
Address 1
1000 Lake Hazeltine Dr.
Statement or summary
Summary
Product code
MOI
Zip code
55318
Applicant
Beckman Coulter, Inc.
Decision date
2024-05-09
Decision code
SESE
Country code
US
Device name
Access BR Monitor
Advisory committee
IM
Contact
Kate Oelberg
K number
K240403
State
MN
Date received
2024-02-09
Review advisory committee
IM
Postal code
55318
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
System, Test, Immunological, Antigen, Tumor
Medical specialty description
Immunology
Regulation number
866.6010
Device class
2
Registration number
2521625, 1036362, 3002642396, 2432235, 3002637618, 2250051, 1319681, 3002806944, 1219913, 9612316, 2122870, 3006198300, 8020888, 3002809144, 3012963943, 3005529799, 3000308930, 3007111389, 3005333358, 8031673, 9610126, 2517506, 2020726, 2032839, 3011989923
FEI number
2521625, 3004185580, 1036362, 3002642396, 2432235, 3002637618, 2250051, 1219913, 3002806944, 2967, 2122870, 3006198300, 3002806559, 3002809144, 3012963943, 1000136573, 3005529799, 3000308930, 3007111389, 3005333358, 2517506, 2020726, 3007019572, 3011989923, 3002808328
Wholesale access for licensed clinicians.

Free to join: your NPI is checked against the federal registry at signup, then wholesale pricing and the professional shelves open.

Join as a DoctorSell on MedGrid

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.