The following data is part of a premarket notification filed by Alere Scarborough, Inc. with the FDA for Alere I Instrument, Alere I Influenza A & B, Alere I Strep A.
| Device ID | K151690 |
| 510k Number | K151690 |
| Device Name: | Alere I Instrument, Alere I Influenza A & B, Alere I Strep A |
| Classification | Real Time Nucleic Acid Amplification 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 | OOI |
| Subsequent Product Code | OCC |
| Subsequent Product Code | OZE |
| Subsequent Product Code | PGX |
| CFR Regulation Number | 862.2570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-06-23 |
| Decision Date | 2015-07-16 |
| Summary: | summary |