The following data is part of a premarket notification filed by Bayer Corp. with the FDA for Acs: 180 And Advia Centaur Theophylline 2 Assay.
| Device ID | K013272 |
| 510k Number | K013272 |
| Device Name: | ACS: 180 AND ADVIA CENTAUR THEOPHYLLINE 2 ASSAY |
| Classification | Enzyme Immunoassay, Theophylline |
| Applicant | BAYER CORP. 511 BENEDICT AVE. Tarrytown, NY 10591 -5097 |
| Contact | Kenneth T Edds |
| Correspondent | Kenneth T Edds BAYER CORP. 511 BENEDICT AVE. Tarrytown, NY 10591 -5097 |
| Product Code | KLS |
| CFR Regulation Number | 862.3880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-10-01 |
| Decision Date | 2001-10-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414460963 | K013272 | 000 |
| 00630414460956 | K013272 | 000 |
| 00630414460918 | K013272 | 000 |