The following data is part of a premarket notification filed by Binax, Inc. with the FDA for Binas Luteinizing Hormone Irma Test Kit.
| Device ID | K883306 |
| 510k Number | K883306 |
| Device Name: | BINAS LUTEINIZING HORMONE IRMA TEST KIT |
| Classification | Calibrator, Secondary |
| 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 | JIT |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-08-04 |
| Decision Date | 1988-10-06 |