The following data is part of a premarket notification filed by Abaxis, Inc. with the FDA for Piccolo(tm) Primary Health Panel Reagent Rotor.
| Device ID | K950164 |
| 510k Number | K950164 |
| Device Name: | PICCOLO(TM) PRIMARY HEALTH PANEL REAGENT ROTOR |
| Classification | Enzymatic Esterase--oxidase, Cholesterol |
| Applicant | ABAXIS, INC. 1320 CHESAPEAKE TERRACE Sunnyvale, CA 94089 |
| Contact | Rodger J Richeal |
| Correspondent | Rodger J Richeal ABAXIS, INC. 1320 CHESAPEAKE TERRACE Sunnyvale, CA 94089 |
| Product Code | CHH |
| Subsequent Product Code | CDN |
| Subsequent Product Code | CEK |
| Subsequent Product Code | CEM |
| Subsequent Product Code | CGA |
| Subsequent Product Code | CGX |
| Subsequent Product Code | CIG |
| Subsequent Product Code | CIJ |
| Subsequent Product Code | CJW |
| Subsequent Product Code | CJY |
| Subsequent Product Code | CKA |
| Subsequent Product Code | CKF |
| CFR Regulation Number | 862.1175 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-01-17 |
| Decision Date | 1995-04-13 |