The following data is part of a premarket notification filed by Bayer Diagnostics Corp. with the FDA for Bayer Valproic Acid Assay For The Acs:180 And Advia Centaur Analyzers.
Device ID | K013959 |
510k Number | K013959 |
Device Name: | BAYER VALPROIC ACID ASSAY FOR THE ACS:180 AND ADVIA CENTAUR ANALYZERS |
Classification | Calibrators, Drug Mixture |
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 | DKB |
CFR Regulation Number | 862.3200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2001-11-30 |
Decision Date | 2002-01-29 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00630414527369 | K013959 | 000 |
00630414527352 | K013959 | 000 |
00630414527345 | K013959 | 000 |
00630414527338 | K013959 | 000 |
00630414527321 | K013959 | 000 |