The following data is part of a premarket notification filed by Em Diagnostic Systems, Inc. with the FDA for Cholesterol (chol) Test Item No. 65410.
| Device ID | K935136 |
| 510k Number | K935136 |
| Device Name: | CHOLESTEROL (CHOL) TEST ITEM NO. 65410 |
| Classification | Enzymatic Esterase--oxidase, Cholesterol |
| Applicant | EM DIAGNOSTIC SYSTEMS, INC. DIV. OF EM INDUSTRIES INC. 480 DEMOCRAT RD. Gibbstown, NJ 08027 |
| Contact | Carol Faulkner |
| Correspondent | Carol Faulkner EM DIAGNOSTIC SYSTEMS, INC. DIV. OF EM INDUSTRIES 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 | 1993-10-28 |
| Decision Date | 1993-12-16 |