The following data is part of a premarket notification filed by Alere Scarborough, Inc with the FDA for Alere I Strep A.
| Device ID | K141757 |
| 510k Number | K141757 |
| Device Name: | ALERE I STREP A |
| Classification | Groups A, C And G Beta-hemolytic Streptococcus 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 | PGX |
| CFR Regulation Number | 866.2680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-06-30 |
| Decision Date | 2015-03-31 |
| Summary: | summary |