The following data is part of a premarket notification filed by Bayer Corp. with the FDA for Procainamide Assay For The Bayer Immuno 1 System.
| Device ID | K971716 |
| 510k Number | K971716 |
| Device Name: | PROCAINAMIDE ASSAY FOR THE BAYER IMMUNO 1 SYSTEM |
| Classification | Enzyme Immunoassay, Procainamide |
| 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 | LAR |
| CFR Regulation Number | 862.3320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-05-09 |
| Decision Date | 1997-06-27 |
| Summary: | summary |