The following data is part of a premarket notification filed by Abbott Diagnostics Scarborough, Inc. with the FDA for Id Now Instrument, Id Now Influenza A & B 2, Id Now Strep A 2.
| Device ID | K220801 |
| 510k Number | K220801 |
| Device Name: | ID Now Instrument, ID Now Influenza A & B 2, ID NOW Strep A 2 |
| Classification | Influenza A And Influenza B Multiplex Nucleic Acid Assay |
| Applicant | Abbott Diagnostics Scarborough, Inc. 10 Southgate Road Scarborough, ME 04074 |
| Contact | Jessica Stahle |
| Correspondent | Jessica Stahle Abbott Diagnostics Scarborough, Inc. 10 Southgate Road Scarborough, ME 04074 |
| Product Code | OZE |
| Subsequent Product Code | OCC |
| Subsequent Product Code | OOI |
| Subsequent Product Code | PGX |
| CFR Regulation Number | 866.3980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-03-18 |
| Decision Date | 2022-06-24 |