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 |