The following data is part of a premarket notification filed by Bayer Diagnostics Corp. with the FDA for Acs 180 Homocysteine Assay.
| Device ID | K013606 |
| 510k Number | K013606 |
| Device Name: | ACS 180 HOMOCYSTEINE ASSAY |
| Classification | Urinary Homocystine (nonquantitative) Test System |
| 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 | LPS |
| CFR Regulation Number | 862.1377 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-10-31 |
| Decision Date | 2001-12-21 |
| Summary: | summary |