The following data is part of a premarket notification filed by Bayer Corp. with the FDA for Hemoglobin Alc (hba1c) & Total Assays For The Technicon Ra/opera Systems In-vitro Diagnostic Systems.
| Device ID | K955087 |
| 510k Number | K955087 |
| Device Name: | HEMOGLOBIN ALC (HBA1C) & TOTAL ASSAYS FOR THE TECHNICON RA/OPERA SYSTEMS IN-VITRO DIAGNOSTIC SYSTEMS |
| Classification | Assay, Glycosylated Hemoglobin |
| 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 | LCP |
| CFR Regulation Number | 864.7470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-11-07 |
| Decision Date | 1996-06-13 |
| Summary: | summary |