The following data is part of a premarket notification filed by Alere Scarborough, Inc with the FDA for Alere Pbp2a Test.
| Device ID | K121905 |
| 510k Number | K121905 |
| Device Name: | ALERE PBP2A TEST |
| Classification | System, Test, Genotypic Detection, Resistant Markers, Staphylococcus Colonies |
| 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 | MYI |
| CFR Regulation Number | 866.1640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-06-29 |
| Decision Date | 2012-07-26 |
| Summary: | summary |