The following data is part of a premarket notification filed by Arkray, Inc. with the FDA for Spotchem Hdl, Total Cholesterol And Triglyceride Reagent Tests And Panel.
| Device ID | K042443 |
| 510k Number | K042443 |
| Device Name: | SPOTCHEM HDL, TOTAL CHOLESTEROL AND TRIGLYCERIDE REAGENT TESTS AND PANEL |
| Classification | Enzymatic Esterase--oxidase, Cholesterol |
| Applicant | ARKRAY, INC. 510 FURNACE DOCK RD. Cortlandt Manor, NY 10567 |
| Contact | Helen Landicho |
| Correspondent | Helen Landicho ARKRAY, INC. 510 FURNACE DOCK RD. Cortlandt Manor, NY 10567 |
| Product Code | CHH |
| Subsequent Product Code | CDT |
| Subsequent Product Code | LBS |
| CFR Regulation Number | 862.1175 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-09-09 |
| Decision Date | 2004-11-24 |