The following data is part of a premarket notification filed by Data Medical Associates, Inc. with the FDA for Triglyceride(trinder) Procedure.
| Device ID | K851538 |
| 510k Number | K851538 |
| Device Name: | TRIGLYCERIDE(TRINDER) PROCEDURE |
| Classification | Lipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides |
| Applicant | DATA MEDICAL ASSOCIATES, INC. 845 AVENUE G EAST Arlington, TX 76011 |
| Contact | Jerry A Graham |
| Correspondent | Jerry A Graham DATA MEDICAL ASSOCIATES, INC. 845 AVENUE G EAST Arlington, TX 76011 |
| Product Code | CDT |
| CFR Regulation Number | 862.1705 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-04-16 |
| Decision Date | 1985-05-20 |