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 |