The following data is part of a premarket notification filed by Sigma Chemical Co. with the FDA for Triglyceride (uv) Reagent.
| Device ID | K872912 |
| 510k Number | K872912 |
| Device Name: | TRIGLYCERIDE (UV) REAGENT |
| Classification | Fluorometric Method, Triglycerides |
| Applicant | SIGMA CHEMICAL CO. P.O. BOX 14508 St. Louis, MO 63178 |
| Contact | Mathew Madappally |
| Correspondent | Mathew Madappally SIGMA CHEMICAL CO. P.O. BOX 14508 St. Louis, MO 63178 |
| Product Code | JGW |
| CFR Regulation Number | 862.1705 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-07-24 |
| Decision Date | 1987-08-17 |