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FDA 510(k)

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

K-Number: K220801 · 2022-06-24

ApplicantAbbott Diagnostics Scarborough, Inc.
Decision Date2022-06-24
Product CodeOZE
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

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

Frequently Asked Questions

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. It is manufactured by Abbott Diagnostics Scarborough, Inc.. The 510(k) number is K220801.

When was ID Now Instrument, ID Now Influenza A & B 2, ID NOW Strep A 2 approved by the FDA?

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

What company makes 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 manufactured by Abbott Diagnostics Scarborough, Inc..

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.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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