The following data is part of a premarket notification filed by U. S. Diagnostics, Inc. with the FDA for U.s. Diagnostics Enzymatic Triglyceride Test.
| Device ID | K864231 |
| 510k Number | K864231 |
| Device Name: | U.S. DIAGNOSTICS ENZYMATIC TRIGLYCERIDE TEST |
| Classification | Lipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides |
| Applicant | U. S. DIAGNOSTICS, INC. P.O. BOX 4522 3443 MIGUELITO COURT San Luis Obispo, CA 93401 |
| Contact | Roy E Speck |
| Correspondent | Roy E Speck U. S. DIAGNOSTICS, INC. P.O. BOX 4522 3443 MIGUELITO COURT San Luis Obispo, CA 93401 |
| Product Code | CDT |
| CFR Regulation Number | 862.1705 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-10-28 |
| Decision Date | 1986-12-04 |