The following data is part of a premarket notification filed by Roche Diagnostic Systems, Inc. with the FDA for Cobas Integra Hdl-cholesterol Direct.
| Device ID | K973284 |
| 510k Number | K973284 |
| Device Name: | COBAS INTEGRA HDL-CHOLESTEROL DIRECT |
| Classification | Enzymatic Esterase--oxidase, Cholesterol |
| Applicant | ROCHE DIAGNOSTIC SYSTEMS, INC. 1080 U.S. HIGHWAY 202 Branchburg, NJ 08876 -1760 |
| Contact | Maria Feijoo |
| Correspondent | Maria Feijoo ROCHE DIAGNOSTIC SYSTEMS, INC. 1080 U.S. HIGHWAY 202 Branchburg, NJ 08876 -1760 |
| Product Code | CHH |
| CFR Regulation Number | 862.1175 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-09-02 |
| Decision Date | 1997-12-18 |
| Summary: | summary |