The following data is part of a premarket notification filed by Technicon Instruments Corp. with the FDA for Technicon Ra Systems For Triglycerides Analysis In.
| Device ID | K854152 |
| 510k Number | K854152 |
| Device Name: | TECHNICON RA SYSTEMS FOR TRIGLYCERIDES ANALYSIS IN |
| Classification | Lipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides |
| Applicant | TECHNICON INSTRUMENTS CORP. 511 BENEDICT AVE. Tarrytown, NY 10591 |
| Contact | Leaonard A Dwarica |
| Correspondent | Leaonard A Dwarica TECHNICON INSTRUMENTS CORP. 511 BENEDICT AVE. Tarrytown, NY 10591 |
| Product Code | CDT |
| CFR Regulation Number | 862.1705 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-10-11 |
| Decision Date | 1985-11-05 |