DeviceClearance

ID Now Instrument, ID Now Influenza A & B 2, ID NOW Strep A 2— 510(k) K220801

Substantially Equivalent

Abbott Diagnostics Scarborough, Inc.

FDA 510(k) clearance K220801 for ID Now Instrument, ID Now Influenza A & B 2, ID NOW Strep A 2, Substantially Equivalent on 2022-06-24. Applicant: Abbott Diagnostics Scarborough, Inc..

Clearance details

Applicant
Abbott Diagnostics Scarborough, Inc.
Product code
Code OZE
Advisory panel
Microbiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Scarborough, ME, US
Download summary PDFView on FDA.gov ↗

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