The following data is part of a premarket notification filed by Binax, Inc. with the FDA for Binaxnow G6pd Test.
| Device ID | K080003 |
| 510k Number | K080003 |
| Device Name: | BINAXNOW G6PD TEST |
| Classification | Glucose-6-phosphate Dehydrogenase (erythrocytic), Screening |
| Applicant | BINAX, INC. 10 SOUTHGATE RD. Scarborough, ME 04074 |
| Contact | Anne Jepson |
| Correspondent | Anne Jepson BINAX, INC. 10 SOUTHGATE RD. Scarborough, ME 04074 |
| Product Code | JBF |
| CFR Regulation Number | 864.7360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-01-02 |
| Decision Date | 2008-10-23 |
| Summary: | summary |