The following data is part of a premarket notification filed by German American Chamber Of Commerce, Inc. with the FDA for Triglycerides Lck 124.
Device ID | K853041 |
510k Number | K853041 |
Device Name: | TRIGLYCERIDES LCK 124 |
Classification | Acid, Vanilmandelic, Diazo, P-nitroaniline/vanillin |
Applicant | GERMAN AMERICAN CHAMBER OF COMMERCE, INC. ONE FARRAGUT-SQUARE SOUTH Washington, DC 20006 |
Contact | Lothar Griessbach |
Correspondent | Lothar Griessbach GERMAN AMERICAN CHAMBER OF COMMERCE, INC. ONE FARRAGUT-SQUARE SOUTH Washington, DC 20006 |
Product Code | CDF |
CFR Regulation Number | 862.1795 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-07-19 |
Decision Date | 1985-08-12 |