The following data is part of a premarket notification filed by Binax, Inc. with the FDA for Binaxnow Malaria Positive Control Kit, Model 665-010.
| Device ID | K083744 |
| 510k Number | K083744 |
| Device Name: | BINAXNOW MALARIA POSITIVE CONTROL KIT, MODEL 665-010 |
| Classification | Kit, Direct Antigen, Positive Control |
| 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 | MJZ |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-12-16 |
| Decision Date | 2009-09-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10811877010712 | K083744 | 000 |