FDA 510(k)

ID Now Instrument, ID Now Influenza A & B 2, ID NOW Strep A 2

Numéro K : K220801 · 2022-06-24

DemandeurAbbott Diagnostics Scarborough, Inc.

Date de décision2022-06-24

Code produitOZE

Comité consultatifMI

DécisionSubstantially Equivalent

Résumé du dispositif

ID Now Instrument, ID Now Influenza A & B 2, ID NOW Strep A 2 is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Diagnostics Scarborough, Inc.. It received FDA 510(k) clearance on 2022-06-24 under 510(k) number K220801. The device is classified under product code OZE. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the ID Now Instrument, ID Now Influenza A & B 2, ID NOW Strep A 2?

ID Now Instrument, ID Now Influenza A & B 2, ID NOW Strep A 2 is a medical device that received FDA 510(k) clearance on 2022-06-24. The listed applicant is Abbott Diagnostics Scarborough, Inc.. The 510(k) number is K220801.

When did ID Now Instrument, ID Now Influenza A & B 2, ID NOW Strep A 2 receive FDA 510(k) clearance?

ID Now Instrument, ID Now Influenza A & B 2, ID NOW Strep A 2 received FDA 510(k) clearance on 2022-06-24, under 510(k) number K220801.

Who is the listed applicant for ID Now Instrument, ID Now Influenza A & B 2, ID NOW Strep A 2?

The FDA 510(k) record lists Abbott Diagnostics Scarborough, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ID Now Instrument, ID Now Influenza A & B 2, ID NOW Strep A 2?

The FDA product code for ID Now Instrument, ID Now Influenza A & B 2, ID NOW Strep A 2 is OZE.

Essais cliniques associés

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Autres dossiers indiquant Abbott Diagnostics Scarborough, Inc. en tant que demandeur

K262747ID NOW Influenza A & B 2; ID NOW RSV; ID NOW Strep A 2; ID NOW COVID-19 2.0 K250273BinaxNOW COVID-19 Ag Card K243518BinaxNOW™ COVID-19 Antigen Self Test K232775ID NOW Influenza A & B 2 K221925ID NOW COVID-19 2.0 K191534ID NOW Influenza A & B 2

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Dispositifs connexes (Code : OZE)

K243274CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel: Influenza A/B Typing Kit (VER 2); Influenza A SubTyping Kit (VER 4); Influenza B Genotyping Kit (VER 1.1 and 2); and Influenza A/H5 Subtyping Kit (VER 4)Centers for Disease Control and Prevention K243931CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel: Influenza A/B Typing Kit (VER 2); Influenza A Subtyping Kit (VER 4); Influenza B Lineage Genotyping Kit (VER 1.1 and 2); and Influenza A/H5 Subtyping Kit (VER 4)Centers for Disease Control and Prevention K241110CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit (Ver4)Centers for Disease Control and Prevention K230236Lyra Influenza A+B AssayQuidel Corporation K200370CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A/B Typing Kit, CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit, CDC Human Influenza Virus Real-time RT-PCR, Influenza A/H5 Subtyping KitCenters for Disease Control and Prevention K182513FluChip-8G Influenza A+B AssayIndevr, Inc.

Source officielle

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