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 |