The following data is part of a premarket notification filed by Alere Scarborough, Inc. with the FDA for Alere I Strep A 2, Alere I Instrument, Alere I Strep A 2 Control Swab Kit.
| Device ID | K173653 |
| 510k Number | K173653 |
| Device Name: | Alere I Strep A 2, Alere I Instrument, Alere I Strep A 2 Control Swab Kit |
| Classification | Groups A, C And G Beta-hemolytic Streptococcus Nucleic Acid Amplification System |
| 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 | PGX |
| CFR Regulation Number | 866.2680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Dual Track |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-11-28 |
| Decision Date | 2018-05-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10811877010200 | K173653 | 000 |
| 10811877010040 | K173653 | 000 |