The following data is part of a premarket notification filed by Bayer Diagnostics Corp. with the FDA for Bayer Valproic Acid Assay For The Acs:180 And Advia Centaur Analyzers.
| Device ID | K013959 |
| 510k Number | K013959 |
| Device Name: | BAYER VALPROIC ACID ASSAY FOR THE ACS:180 AND ADVIA CENTAUR ANALYZERS |
| Classification | Calibrators, Drug Mixture |
| 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 | DKB |
| CFR Regulation Number | 862.3200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-11-30 |
| Decision Date | 2002-01-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414527369 | K013959 | 000 |
| 00630414527352 | K013959 | 000 |
| 00630414527345 | K013959 | 000 |
| 00630414527338 | K013959 | 000 |
| 00630414527321 | K013959 | 000 |