The following data is part of a premarket notification filed by Biotrol, Usa, Inc. with the FDA for Biotrol Triglycerides Enzymatique Color.
| Device ID | K873160 |
| 510k Number | K873160 |
| Device Name: | BIOTROL TRIGLYCERIDES ENZYMATIQUE COLOR |
| Classification | Lipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides |
| Applicant | BIOTROL, USA, INC. P.O. BOX 562 Berwyn, PA 19312 |
| Contact | Allan C Murphy |
| Correspondent | Allan C Murphy BIOTROL, USA, INC. P.O. BOX 562 Berwyn, PA 19312 |
| Product Code | CDT |
| CFR Regulation Number | 862.1705 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-08-11 |
| Decision Date | 1987-09-08 |