The following data is part of a premarket notification filed by Abaxis, Inc. with the FDA for Piccolo Sodium Test System.
| Device ID | K993211 |
| 510k Number | K993211 |
| Device Name: | PICCOLO SODIUM TEST SYSTEM |
| Classification | Electrode, Ion Specific, Sodium |
| Applicant | ABAXIS, INC. 1320 CHESAPEAKE TERRACE Sunnyvale, CA 94089 |
| Contact | Lisa Mcgrath |
| Correspondent | Lisa Mcgrath ABAXIS, INC. 1320 CHESAPEAKE TERRACE Sunnyvale, CA 94089 |
| Product Code | JGS |
| CFR Regulation Number | 862.1665 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-09-24 |
| Decision Date | 1999-10-25 |
| Summary: | summary |