The following data is part of a premarket notification filed by Technicon Instruments Corp. with the FDA for Technicon Chem 1(tm) Syst (gen2 Syst).
| Device ID | K914888 |
| 510k Number | K914888 |
| Device Name: | TECHNICON CHEM 1(TM) SYST (GEN2 SYST) |
| Classification | Bromcresol Green Dye-binding, Albumin |
| Applicant | TECHNICON INSTRUMENTS CORP. 511 BENEDICT AVE. Tarrytown, NY 10591 |
| Contact | Thomas C Brewster |
| Correspondent | Thomas C Brewster TECHNICON INSTRUMENTS CORP. 511 BENEDICT AVE. Tarrytown, NY 10591 |
| Product Code | CIX |
| CFR Regulation Number | 862.1035 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-10-30 |
| Decision Date | 1991-11-27 |