The following data is part of a premarket notification filed by Abaxis, Inc. with the FDA for Piccolo Potassium Test System.
Device ID | K200865 |
510k Number | K200865 |
Device Name: | Piccolo Potassium Test System |
Classification | Test, System, Potassium, Enzymatic Method |
Applicant | Abaxis, Inc. 3240 Whipple Road Union City, CA 94587 |
Contact | Dennis M Bleile |
Correspondent | Julie Schoell Zoetis LLC (acquirer Of Abaxis, Inc.) 3240 Whipple Road Union City, CA 94587 |
Product Code | MZV |
CFR Regulation Number | 862.1600 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Dual Track |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2020-04-01 |
Decision Date | 2021-10-20 |