The following data is part of a premarket notification filed by Abaxis, Inc. with the FDA for Piccolo Total Cholesterol Test System.
| Device ID | K023642 |
| 510k Number | K023642 |
| Device Name: | PICCOLO TOTAL CHOLESTEROL TEST SYSTEM |
| Classification | Enzymatic Esterase--oxidase, Cholesterol |
| Applicant | ABAXIS, INC. 3240 WHIPPLE RD. Union City, CA 94587 |
| Contact | Dennis M Bleile |
| Correspondent | Dennis M Bleile ABAXIS, INC. 3240 WHIPPLE RD. Union City, CA 94587 |
| Product Code | CHH |
| CFR Regulation Number | 862.1175 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-10-30 |
| Decision Date | 2003-01-24 |
| Summary: | summary |