The following data is part of a premarket notification filed by Binax, Inc. with the FDA for Binax Prolactin Irma Diagnostic Kit.
| Device ID | K880218 |
| 510k Number | K880218 |
| Device Name: | BINAX PROLACTIN IRMA DIAGNOSTIC KIT |
| Classification | Radioimmunoassay, Prolactin (lactogen) |
| Applicant | BINAX, INC. 95 DARLING AVE. S. Portland, ME 04106 |
| Contact | Lee Brown |
| Correspondent | Lee Brown BINAX, INC. 95 DARLING AVE. S. Portland, ME 04106 |
| Product Code | CFT |
| CFR Regulation Number | 862.1625 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-01-20 |
| Decision Date | 1988-03-01 |