510(k) clearances

DASH Flu A/B Test

Nuclein, LLC · Microbiology

K261347Substantially EquivalentDual TrackOCC
Open FDA's page for this record
Third party flag
N
City
Austin
Advisory committee description
Microbiology
Address 1
8305 Cross Park Dr.
Statement or summary
Summary
Product code
OCC
Zip code
78754
Applicant
Nuclein, LLC
Decision date
2026-10-21
Decision code
SESE
Country code
US
Device name
DASH Flu A/B Test
Advisory committee
MI
Contact
Ben Treece
K number
K261347
State
TX
Date received
2026-04-24
Review advisory committee
MI
Postal code
78754
Decision description
Substantially Equivalent
Clearance type
Dual Track
Harmonized identifiers (openFDA)
Device name
Respiratory Virus Panel Nucleic Acid Assay System
Medical specialty description
Microbiology
Regulation number
866.3980
Device class
2
Registration number
1528450, 3003030793, 2024800, 3005360469, 2243471, 3003795116, 3003018722, 3016838963, 3009613136, 3002773840, 3006198300, 2023365, 3021140368, 3004530258, 3013019728, 3004141078, 3010749841, 3023999024, 1221359, 9681630, 3006028115, 3002777243, 3012494290, 3038610665, 3005248192, 9610126, 1650733, 3008632402, 3029059580, 3023372670, 3010770794, 3007799234
FEI number
3003030793, 2024800, 2243471, 3003795116, 3003018722, 3016838963, 3009613136, 1000122536, 3002773840, 3006198300, 2023365, 3002524000, 3021140368, 3004530258, 3002806559, 3013019728, 3002808845, 3004141078, 3010749841, 3023999024, 1221359, 3006028115, 3002777243, 3012494290, 3038610665, 3005248192, 3008632402, 3029059580, 3023372670, 3010770794, 3007799234, 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.