The following data is part of a premarket notification filed by Em Diagnostic Systems, Inc. with the FDA for Abbott Quickstart Cholesterol Test.
| Device ID | K913565 |
| 510k Number | K913565 |
| Device Name: | ABBOTT QUICKSTART CHOLESTEROL TEST |
| Classification | Enzymatic Esterase--oxidase, Cholesterol |
| Applicant | EM DIAGNOSTIC SYSTEMS, INC. 480 DEMOCRAT RD. Gibbstown, NJ 08027 |
| Contact | Anna Bentley |
| Correspondent | Anna Bentley EM DIAGNOSTIC SYSTEMS, INC. 480 DEMOCRAT RD. Gibbstown, NJ 08027 |
| Product Code | CHH |
| CFR Regulation Number | 862.1175 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-08-09 |
| Decision Date | 1991-12-18 |