The following data is part of a premarket notification filed by Abbott Diagnostics Scarborough, Inc. with the FDA for Id Now Influenza A & B 2.
| Device ID | K191534 |
| 510k Number | K191534 |
| Device Name: | ID NOW Influenza A & B 2 |
| Classification | Respiratory Virus Panel Nucleic Acid Assay System |
| Applicant | Abbott Diagnostics Scarborough, Inc. 10 Southgate Road Scarborough, ME 04074 |
| Contact | Angela Drysdale |
| Correspondent | Angela Drysdale Abbott Diagnostics Scarborough, Inc. 10 Southgate Road Scarborough, ME 04074 |
| Product Code | OCC |
| Subsequent Product Code | OOI |
| Subsequent Product Code | OZE |
| CFR Regulation Number | 866.3980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-06-10 |
| Decision Date | 2019-07-11 |