The following data is part of a premarket notification filed by Bayer Corp. with the FDA for Bayer Advia Ims System (in Vitro Diagnostic System).
| Device ID | K982328 |
| 510k Number | K982328 |
| Device Name: | BAYER ADVIA IMS SYSTEM (IN VITRO DIAGNOSTIC SYSTEM) |
| Classification | Alpha-naphthyl Phosphate, Alkaline Phosphatase Or Isoenzymes |
| 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 | CJO |
| Subsequent Product Code | CFR |
| Subsequent Product Code | CIC |
| Subsequent Product Code | DHA |
| Subsequent Product Code | JLW |
| Subsequent Product Code | JMG |
| CFR Regulation Number | 862.1050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-07-02 |
| Decision Date | 1999-01-29 |
| Summary: | summary |