The following data is part of a premarket notification filed by Technicon Instruments Corp. with the FDA for Technicon Gen 2 Sys & Analytes Ld, Alp Ck, Un, In.
| Device ID | K850999 |
| 510k Number | K850999 |
| Device Name: | TECHNICON GEN 2 SYS & ANALYTES LD, ALP CK, UN, IN |
| Classification | Analyzer, Chemistry, Micro, For Clinical Use |
| Applicant | TECHNICON INSTRUMENTS CORP. 511 BENEDICT AVE. Tarrytown, NY 10591 |
| Contact | Leonard A Dwarica |
| Correspondent | Leonard A Dwarica TECHNICON INSTRUMENTS CORP. 511 BENEDICT AVE. Tarrytown, NY 10591 |
| Product Code | JJF |
| CFR Regulation Number | 862.2170 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-03-11 |
| Decision Date | 1985-04-08 |