510(k) clearances

Access OV Monitor

Beckman Coulter, Inc. · Immunology

K240479Substantially EquivalentTraditionalLTK
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
LTK
Zip code
55318
Applicant
Beckman Coulter, Inc.
Decision date
2024-05-10
Decision code
SESE
Country code
US
Device name
Access OV Monitor
Advisory committee
IM
Contact
Kuljeet Kaur
K number
K240479
State
MN
Date received
2024-02-20
Review advisory committee
IM
Postal code
55318
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125)
Medical specialty description
Immunology
Regulation number
866.6010
Device class
2
Registration number
2521625, 1036362, 3005360469, 3002642396, 2432235, 2250051, 3014643041, 1319681, 3002806944, 1219913, 3004192065, 9612316, 2122870, 1643621, 3006198300, 8020888, 3002809144, 3012963943, 3005529799, 3000308930, 3002895169, 3007111389, 3005333358, 8031673, 3005622096, 9610126, 2517506, 2020726, 2032839, 3011989923
FEI number
2521625, 3004185580, 1036362, 3002642396, 2432235, 2250051, 3014643041, 1219913, 3002806944, 3004192065, 2967, 2122870, 1643621, 3006198300, 3002806559, 3002809144, 3012963943, 1000136573, 3005529799, 3000308930, 3002895169, 3007111389, 3005333358, 3005622096, 2517506, 2020726, 3007019572, 3011989923, 3002808328, 3005670738
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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.