The following data is part of a premarket notification filed by Pointe Scientific, Inc. with the FDA for Triglycerides.
| Device ID | K862033 |
| 510k Number | K862033 |
| Device Name: | TRIGLYCERIDES |
| Classification | Lipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides |
| Applicant | POINTE SCIENTIFIC, INC. P.O. BOX 8569 Detroit, MI 48224 |
| Contact | Janusz M Szyszko |
| Correspondent | Janusz M Szyszko POINTE SCIENTIFIC, INC. P.O. BOX 8569 Detroit, MI 48224 |
| Product Code | CDT |
| CFR Regulation Number | 862.1705 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-05-28 |
| Decision Date | 1986-07-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00811727015129 | K862033 | 000 |
| 00811727016287 | K862033 | 000 |
| 00817439021311 | K862033 | 000 |
| 00817439021335 | K862033 | 000 |
| 00811727012098 | K862033 | 000 |
| 00811727012104 | K862033 | 000 |
| 00811727012784 | K862033 | 000 |
| 00811727013668 | K862033 | 000 |
| 00811727014429 | K862033 | 000 |
| 00811727014443 | K862033 | 000 |
| 00811727014825 | K862033 | 000 |
| 00811727015983 | K862033 | 000 |