The following data is part of a premarket notification filed by Pointe Scientific, Inc. with the FDA for Enzymatic Triglyceride.
| Device ID | K810680 |
| 510k Number | K810680 |
| Device Name: | ENZYMATIC TRIGLYCERIDE |
| Classification | Lipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides |
| Applicant | POINTE SCIENTIFIC, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | CDT |
| CFR Regulation Number | 862.1705 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-03-13 |
| Decision Date | 1981-03-31 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00811727014412 | K810680 | 000 |
| 00811727012111 | K810680 | 000 |