The following data is part of a premarket notification filed by Biotrol, Usa, Inc. with the FDA for Biotrol Triglycerides Enzymatique Uv H.p..
Device ID | K881702 |
510k Number | K881702 |
Device Name: | BIOTROL TRIGLYCERIDES ENZYMATIQUE UV H.P. |
Classification | Lipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides |
Applicant | BIOTROL, USA, INC. 5 GREAT VALLEY PKWY, SUITE 248 GREAT VALLEY CORP. CENTER Malvern, PA 19355 |
Contact | Allan C Murphy |
Correspondent | Allan C Murphy BIOTROL, USA, INC. 5 GREAT VALLEY PKWY, SUITE 248 GREAT VALLEY CORP. CENTER Malvern, PA 19355 |
Product Code | CDT |
CFR Regulation Number | 862.1705 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-04-19 |
Decision Date | 1988-05-27 |