The following data is part of a premarket notification filed by Alere Scarborough, Inc. with the FDA for Alere I Influenza A & B, Alere I Instrument, Alere I Influenza A & B Control Swab Kit.
| Device ID | K151464 |
| 510k Number | K151464 |
| Device Name: | Alere I Influenza A & B, Alere I Instrument, Alere I Influenza A & B Control Swab Kit |
| Classification | Respiratory Virus Panel Nucleic Acid Assay System |
| Applicant | ALERE SCARBOROUGH, INC. 10 SOUTHGATE ROAD Scarborough, ME 04074 |
| Contact | Angela Drysdale |
| Correspondent | Angela Drysdale ALERE 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-06-01 |
| Decision Date | 2015-07-28 |
| Summary: | summary |