The following data is part of a premarket notification filed by Bayer Healthcare, Llc with the FDA for Advia Centaur And Acs:180 Liquid Cardiac Markers 1, 2, 3.
| Device ID | K030102 |
| 510k Number | K030102 |
| Device Name: | ADVIA CENTAUR AND ACS:180 LIQUID CARDIAC MARKERS 1, 2, 3 |
| Classification | Enzyme Controls (assayed And Unassayed) |
| Applicant | BAYER HEALTHCARE, LLC 511 BENEDICT AVE. Tarrytown, NY 10591 |
| Contact | Kenneth T Edds |
| Correspondent | Kenneth T Edds BAYER HEALTHCARE, LLC 511 BENEDICT AVE. Tarrytown, NY 10591 |
| Product Code | JJT |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-01-10 |
| Decision Date | 2003-01-24 |
| Summary: | summary |