The following data is part of a premarket notification filed by Alere Scarborough, Inc D/b/a Binax, Inc. with the FDA for Alere I Influenza A & B.
| Device ID | K141520 |
| 510k Number | K141520 |
| Device Name: | ALERE I INFLUENZA A & B |
| Classification | Respiratory Virus Panel Nucleic Acid Assay System |
| Applicant | ALERE SCARBOROUGH, INC D/B/A BINAX, INC. 10 Southgate Rd Scarborough, ME 04074 |
| Contact | Angela Drysdale |
| Correspondent | Angela Drysdale ALERE SCARBOROUGH, INC D/B/A BINAX, INC. 10 Southgate Rd 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 | 2014-06-09 |
| Decision Date | 2014-06-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10811877010811 | K141520 | 000 |
| 10811877010804 | K141520 | 000 |
| 00811877010838 | K141520 | 000 |
| 00811877010821 | K141520 | 000 |
| 00811877010616 | K141520 | 000 |
| 00811877010593 | K141520 | 000 |