The following data is part of a premarket notification filed by Bayer Corp. with the FDA for Unconjugated Estriol Assay For The Bayer Immuno 1 System (in Vitro Diagnostic System).
| Device ID | K974721 |
| 510k Number | K974721 |
| Device Name: | UNCONJUGATED ESTRIOL ASSAY FOR THE BAYER IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM) |
| Classification | Radioimmunoassay, Estriol |
| Applicant | BAYER CORP. 511 BENEDICT AVE. Tarrytown, NY 10591 -5097 |
| Contact | Gabriel J Muraca Jr. |
| Correspondent | Gabriel J Muraca Jr. BAYER CORP. 511 BENEDICT AVE. Tarrytown, NY 10591 -5097 |
| Product Code | CGI |
| CFR Regulation Number | 862.1265 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-12-18 |
| Decision Date | 1998-03-03 |
| Summary: | summary |