The following data is part of a premarket notification filed by Em Diagnostic Systems, Inc. with the FDA for Systemate Triglyceriides (epos Application) #65477.
| Device ID | K910638 |
| 510k Number | K910638 |
| Device Name: | SYSTEMATE TRIGLYCERIIDES (EPOS APPLICATION) #65477 |
| Classification | Lipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides |
| Applicant | EM DIAGNOSTIC SYSTEMS, INC. 480 DEMOCRAT RD. Gibbstown, NJ 08027 |
| Contact | Anna G Bentley |
| Correspondent | Anna G Bentley EM DIAGNOSTIC SYSTEMS, INC. 480 DEMOCRAT RD. Gibbstown, NJ 08027 |
| Product Code | CDT |
| CFR Regulation Number | 862.1705 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-02-13 |
| Decision Date | 1991-03-11 |