Atlas FDA

ID NOW Influenza A & B 2

FDA 510(k) clearance K232775 · decided 2023-10-10

Clearance details

K-number
K232775
Device name
ID NOW Influenza A & B 2
Applicant
Abbott Diagnostics Scarborough, Inc.
Decision
Substantially Equivalent
Date received
2023-09-11
Decision date
2023-10-10
Days to decision
29 days
Clearance type
Special
Product code
OCC
Device class
2
Regulation number
866.3980
Medical specialty
Microbiology
Advisory committee
Microbiology
Location
Scarborough, ME, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Brand Name: ID NOW Influenza A/B 2 24T Product Name: ID NOW Influenza A/B 2 24T Model/Cata recall (Z-1572-2025)Abbott Diagnostics Scarborough, Inc.2025-04-15
Brand Name: ID NOW Influenza A/B 2 24T Product Name: ID NOW Influenza A/B 2 24T Model/Cata recall (Z-1575-2025)Abbott Diagnostics Scarborough, Inc.2025-04-15

PMA approvals by this applicant

RecordFirmDate
NMP22 BladderChek Test (P940035/S017)Abbott Diagnostics Scarborough, Inc.2022-07-12
Alere NMP22 BladderChek Test (P940035/S016)Abbott Diagnostics Scarborough, Inc.2021-06-15
Alere NMP22 BladderChek Test (P940035/S015)Abbott Diagnostics Scarborough, Inc.2018-05-17
MATRITECH NMP22(TM) TEST KIT (P940035/S014)Abbott Diagnostics Scarborough, Inc.2017-02-27
Alere NMP22 BladderChek Test (P940035/S013)Abbott Diagnostics Scarborough, Inc.2016-09-08
ALERE NMP22(TM) TEST (P940035/S012)Abbott Diagnostics Scarborough, Inc.2016-05-06
ALERE NMP22 BLADDERCHEK TEST (P940035/S011)Abbott Diagnostics Scarborough, Inc.2015-07-28
ALERE NMP22 TEST (P940035/S010)Abbott Diagnostics Scarborough, Inc.2013-07-16