The following data is part of a premarket notification filed by Bayer Diagnostics Corp. with the FDA for Bayer Ligand Plus 1, 2, 3 Controls.
| Device ID | K030452 |
| 510k Number | K030452 |
| Device Name: | BAYER LIGAND PLUS 1, 2, 3 CONTROLS |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| Applicant | BAYER DIAGNOSTICS CORP. 511 BENEDICT AVE. Tarrytown, NY 10591 -5097 |
| Contact | Kenneth T Edds |
| Correspondent | Kenneth T Edds BAYER DIAGNOSTICS CORP. 511 BENEDICT AVE. Tarrytown, NY 10591 -5097 |
| Product Code | JJY |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-02-11 |
| Decision Date | 2003-03-03 |
| Summary: | summary |