The following data is part of a premarket notification filed by Union Carbide Corp. with the FDA for Centrifichem Triglyceride Cali. Std..
Device ID | K771215 |
510k Number | K771215 |
Device Name: | CENTRIFICHEM TRIGLYCERIDE CALI. STD. |
Classification | Calibrator, Secondary |
Applicant | UNION CARBIDE CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | JIT |
CFR Regulation Number | 862.1150 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1977-07-05 |
Decision Date | 1977-07-21 |