The following data is part of a premarket notification filed by Binax, Inc. with the FDA for Binax Fsh Irma Test Kit, Immunoradiometric Assay.
| Device ID | K883305 |
| 510k Number | K883305 |
| Device Name: | BINAX FSH IRMA TEST KIT, IMMUNORADIOMETRIC ASSAY |
| Classification | Radioimmunoassay, Follicle-stimulating Hormone |
| Applicant | BINAX, INC. 95 DARLING AVE. S. Portland, ME 04106 |
| Contact | Bruce F Watkins |
| Correspondent | Bruce F Watkins BINAX, INC. 95 DARLING AVE. S. Portland, ME 04106 |
| Product Code | CGJ |
| CFR Regulation Number | 862.1300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-08-04 |
| Decision Date | 1988-10-06 |