510(k) clearances

Access BNP II

Beckman Coulter, Inc. · Clinical Chemistry

K262597Substantially EquivalentTraditionalNBC
Open FDA's page for this record
Third party flag
N
City
Chaska
Advisory committee description
Clinical Chemistry
Address 1
1000 Lake Hazeltine Dr.
Statement or summary
Summary
Product code
NBC
Zip code
55318
Applicant
Beckman Coulter, Inc.
Decision date
2026-10-20
Decision code
SESE
Country code
US
Device name
Access BNP II
Advisory committee
CH
Contact
Beth Davis
K number
K262597
State
MN
Date received
2026-07-27
Review advisory committee
CH
Postal code
55318
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Test, Natriuretic Peptide
Medical specialty description
Clinical Chemistry
Regulation number
862.1117
Device class
2
Registration number
2521625, 2032682, 3005360469, 3002642396, 2432235, 3002637618, 2250051, 3004192065, 1219913, 1319681, 9612316, 3010825766, 3029973107, 2122870, 3006198300, 8020888, 2245578, 9610987, 3002809144, 3012963943, 3005529799, 3000308930, 3007111389, 3005333358, 8031673, 3005174594, 2246703, 9610126, 2435505, 2517506, 8032314, 3004205692, 2032839, 3011989923, 3013982035, 3014353045, 3005643513
FEI number
2521625, 3004185580, 3002642396, 2432235, 3002637618, 2250051, 3004192065, 1219913, 3029973107, 3010825766, 2967, 2122870, 3006198300, 3002806559, 1000119795, 3003952975, 2245578, 3002809144, 3012963943, 1000136573, 3005529799, 3000308930, 3007111389, 3005333358, 3005174594, 2246703, 2517506, 3002807710, 3004205692, 3007019572, 3011989923, 3002808140, 3013982035, 3014353045, 3005643513, 3002808328, 3005670738
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.

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.