The following data is part of a premarket notification filed by Bayer Healthcare, Diagnostics Division with the FDA for Advia Chemistry Glucose Oxidase Assay And Advia Chemistry Glucose Hexokinase.
Device ID | K042015 |
510k Number | K042015 |
Device Name: | ADVIA CHEMISTRY GLUCOSE OXIDASE ASSAY AND ADVIA CHEMISTRY GLUCOSE HEXOKINASE |
Classification | Glucose Oxidase, Glucose |
Applicant | BAYER HEALTHCARE, DIAGNOSTICS DIVISION 511 BENEDICT AVE. Tarrytown, NY 10591 |
Contact | Andres Holle |
Correspondent | Andres Holle BAYER HEALTHCARE, DIAGNOSTICS DIVISION 511 BENEDICT AVE. Tarrytown, NY 10591 |
Product Code | CGA |
CFR Regulation Number | 862.1345 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2004-07-27 |
Decision Date | 2004-09-29 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00630414595634 | K042015 | 000 |
00630414578941 | K042015 | 000 |
00630414526720 | K042015 | 000 |