The following data is part of a premarket notification filed by Binax, Inc. with the FDA for Binax Equate Glycohemoglobin.
| Device ID | K874749 |
| 510k Number | K874749 |
| Device Name: | BINAX EQUATE GLYCOHEMOGLOBIN |
| Classification | Assay, Glycosylated Hemoglobin |
| Applicant | BINAX, INC. 95 DARLING AVE. S. Portland, ME 04106 |
| Contact | Kelsey, Phd |
| Correspondent | Kelsey, Phd BINAX, INC. 95 DARLING AVE. S. Portland, ME 04106 |
| Product Code | LCP |
| CFR Regulation Number | 864.7470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-11-18 |
| Decision Date | 1988-08-12 |