FDA.report

510(k) K232775

Device
ID NOW Influenza A & B 2
Applicant
Abbott Diagnostics Scarborough, Inc.
510(k) number
K232775
Product code
OCC
Decision
Substantially Equivalent (SESE)
Decision date
2023-10-10
Date received
2023-09-11
Regulation
866.3980
Classification name
Respiratory Virus Panel Nucleic Acid Assay System
Medical specialty
Microbiology
Review panel
Microbiology
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No

Related Records

Applicant Contact

Contact
Jessica Stahle
Address
10 Southgate Rd. Scarborough ME US 04074 04074

FDA Registration Numbers

Source Documents

510(k) summary PDF

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