The following data is part of a premarket notification filed by Kmi Diagnostics, Inc. with the FDA for 17 B-estradiol (elisa).
| Device ID | K973901 |
| 510k Number | K973901 |
| Device Name: | 17 B-ESTRADIOL (ELISA) |
| Classification | Radioimmunoassay, Estradiol |
| Applicant | KMI DIAGNOSTICS, INC. 818 51ST AVE., N.E. SUITE 101 Minneapolis, MN 55421 |
| Contact | Mark A Kowal |
| Correspondent | Mark A Kowal KMI DIAGNOSTICS, INC. 818 51ST AVE., N.E. SUITE 101 Minneapolis, MN 55421 |
| Product Code | CHP |
| CFR Regulation Number | 862.1260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-10-14 |
| Decision Date | 1997-11-24 |