The following data is part of a premarket notification filed by Fermco Biochemics, Inc. with the FDA for Triglycerides Reagent System.
| Device ID | K843832 |
| 510k Number | K843832 |
| Device Name: | TRIGLYCERIDES REAGENT SYSTEM |
| Classification | Lipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides |
| Applicant | FERMCO BIOCHEMICS, INC. 2020 LUNT AVENUE Elk Grove Village , IL 60007 - |
| Contact | Frank E Hammer |
| Correspondent | Frank E Hammer FERMCO BIOCHEMICS, INC. 2020 LUNT AVENUE Elk Grove Village , IL 60007 - |
| Product Code | CDT |
| CFR Regulation Number | 862.1705 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-10-01 |
| Decision Date | 1984-11-27 |