510(k) clearances

Alinity h-series System

Abbott Laboratories · Hematology

K243283Substantially EquivalentTraditionalGKZ
Open FDA's page for this record
Third party flag
N
City
Santa Clara
Advisory committee description
Hematology
Address 1
4551 Great America Pkwy.
Statement or summary
Summary
Product code
GKZ
Zip code
95054
Applicant
Abbott Laboratories
Decision date
2025-02-20
Decision code
SESE
Country code
US
Device name
Alinity h-series System
Advisory committee
HE
Contact
Saloni Shah
K number
K243283
State
CA
Date received
2024-10-17
Review advisory committee
HE
Postal code
95054
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Counter, Differential Cell
Medical specialty description
Hematology
Regulation number
864.5220
Device class
2
Registration number
3004008703, 1036362, 3010421384, 3007113174, 3010960914, 3007349751, 3006412379, 2432235, 3005146313, 3009297077, 3016090200, 1064608, 3006946274, 1000292377, 3000148879, 3003589956, 3003630693, 3003423869, 3003601075, 3006198300, 3014053517, 3009495621, 1221433, 1017835, 3007603826, 8023018, 8020888, 3010324880, 2032112, 3002809144, 3002759288, 3008352382, 3009711478, 3009189893, 1181121, 3038625004, 3013445220, 3008096179, 9610099, 1950302 +22 more
FEI number
3004008703, 1036362, 3010421384, 3002807272, 3007113174, 3010960914, 3007349751, 3006412379, 3002806778, 2432235, 3005146313, 3009297077, 3016090200, 3006946274, 1000292377, 3000148879, 3003589956, 6137, 3003630693, 3003423869, 3003601075, 3006198300, 3014053517, 3009495621, 1221433, 1017835, 3007603826, 3010324880, 3002809144, 3002759288, 3008352382, 3009711478, 3009189893, 1181121, 3038625004, 3013445220, 3008096179, 1950302, 3008425728, 3039523350 +22 more
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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.