The following data is part of a premarket notification filed by Hitachi Chemical Diagnostics, Inc. with the FDA for Hitachi Clinical Analyzer S Test Reagent Catridge For: Cholestrol, Hdl, Ldl, And Triglyceride.
| Device ID | K111753 |
| 510k Number | K111753 |
| Device Name: | HITACHI CLINICAL ANALYZER S TEST REAGENT CATRIDGE FOR: CHOLESTROL, HDL, LDL, AND TRIGLYCERIDE |
| Classification | Enzymatic Esterase--oxidase, Cholesterol |
| Applicant | HITACHI CHEMICAL DIAGNOSTICS, INC. 575 Shirlynn Court Los Altos, CA 94022 |
| Contact | Erika B Ammirati, Rac, Mt (ascp) |
| Correspondent | Erika B Ammirati, Rac, Mt (ascp) HITACHI CHEMICAL DIAGNOSTICS, INC. 575 Shirlynn Court Los Altos, CA 94022 |
| Product Code | CHH |
| Subsequent Product Code | CDT |
| Subsequent Product Code | JJE |
| Subsequent Product Code | LBS |
| Subsequent Product Code | MRR |
| CFR Regulation Number | 862.1175 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-06-22 |
| Decision Date | 2011-12-14 |
| Summary: | summary |