The following data is part of a premarket notification filed by Alere Scarborough, Inc with the FDA for Alere Pbp2a Sa/cons Culture Colony Test.
| Device ID | K133851 |
| 510k Number | K133851 |
| Device Name: | ALERE PBP2A SA/CONS CULTURE COLONY TEST |
| Classification | System, Test, Genotypic Detection, Resistant Markers, Staphylococcus Colonies |
| Applicant | ALERE SCARBOROUGH, INC 10 Southgate Road Scarborough, ME 04074 |
| Contact | Danielle A Briggeman |
| Correspondent | Danielle A Briggeman ALERE SCARBOROUGH, INC 10 Southgate Road Scarborough, ME 04074 |
| Product Code | MYI |
| CFR Regulation Number | 866.1640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-12-19 |
| Decision Date | 2014-09-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10811877011238 | K133851 | 000 |
| 10811877010842 | K133851 | 000 |