The following data is part of a premarket notification filed by Alere Scarborough, Inc. with the FDA for Binaxnow G6pd Test.
| Device ID | K161364 |
| 510k Number | K161364 |
| Device Name: | BinaxNOW G6PD Test |
| Classification | Glucose-6-phosphate Dehydrogenase (erythrocytic), Screening |
| 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 | JBF |
| CFR Regulation Number | 864.7360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-05-17 |
| Decision Date | 2016-06-17 |
| Summary: | summary |