The following data is part of a premarket notification filed by Technicon Instruments Corp. with the FDA for Technicon Dax(tm) System.
| Device ID | K885203 |
| 510k Number | K885203 |
| Device Name: | TECHNICON DAX(TM) SYSTEM |
| Classification | Analyzer, Chemistry, Centrifugal, For Clinical Use |
| Applicant | TECHNICON INSTRUMENTS CORP. 511 BENEDICT AVE. Tarrytown, NY 10591 |
| Contact | A Dwarica |
| Correspondent | A Dwarica TECHNICON INSTRUMENTS CORP. 511 BENEDICT AVE. Tarrytown, NY 10591 |
| Product Code | JJG |
| CFR Regulation Number | 862.2140 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-12-19 |
| Decision Date | 1989-03-28 |