The following data is part of a premarket notification filed by Olympus America, Inc. with the FDA for Olympus Triglyceride Test System.
| Device ID | K063804 |
| 510k Number | K063804 |
| Device Name: | OLYMPUS TRIGLYCERIDE TEST SYSTEM |
| Classification | Lipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides |
| Applicant | OLYMPUS AMERICA, INC. 3131 WEST ROYAL LN. Irving, TX 75063 -3104 |
| Contact | Bev Harding |
| Correspondent | Bev Harding OLYMPUS AMERICA, INC. 3131 WEST ROYAL LN. Irving, TX 75063 -3104 |
| Product Code | CDT |
| CFR Regulation Number | 862.1705 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-12-22 |
| Decision Date | 2007-03-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15099590060145 | K063804 | 000 |
| 15099590011093 | K063804 | 000 |
| 15099590000356 | K063804 | 000 |