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 |