The following data is part of a premarket notification filed by Binax, Inc. with the FDA for Binax Irma Total Beta-hcg Test Kit.
| Device ID | K872728 |
| 510k Number | K872728 |
| Device Name: | BINAX IRMA TOTAL BETA-HCG TEST KIT |
| Classification | Visual, Pregnancy Hcg, Prescription Use |
| Applicant | BINAX, INC. 95 DARLING AVE. S. Portland, ME 04106 |
| Contact | Watkins, Phd |
| Correspondent | Watkins, Phd BINAX, INC. 95 DARLING AVE. S. Portland, ME 04106 |
| Product Code | JHI |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-07-08 |
| Decision Date | 1987-08-05 |