The following data is part of a premarket notification filed by Bayer Diagnostics Corp. with the FDA for Advia 120 Hematology System Complete Blood Count (cbc) Method.
Device ID | K022668 |
510k Number | K022668 |
Device Name: | ADVIA 120 HEMATOLOGY SYSTEM COMPLETE BLOOD COUNT (CBC) METHOD |
Classification | Counter, Differential Cell |
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 | GKZ |
CFR Regulation Number | 864.5220 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-08-12 |
Decision Date | 2002-10-15 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00630414558400 | K022668 | 000 |