The following data is part of a premarket notification filed by Bayer Diagnostics Corp. with the FDA for Uric Acid Assay For The Advia Integrated Modular System.
Device ID | K022096 |
510k Number | K022096 |
Device Name: | URIC ACID ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM |
Classification | Acid, Uric, Uricase (colorimetric) |
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 | KNK |
CFR Regulation Number | 862.1775 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-06-27 |
Decision Date | 2003-03-18 |
Summary: | summary |