The following data is part of a premarket notification filed by Technicon Instruments Corp. with the FDA for Technicon Ra-xt(tm) System Immunoassays.
Device ID | K870998 |
510k Number | K870998 |
Device Name: | TECHNICON RA-XT(TM) SYSTEM IMMUNOASSAYS |
Classification | Analyzer, Chemistry (sequential Multiple, Continuous Flow) 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 | JJC |
CFR Regulation Number | 862.2150 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-03-11 |
Decision Date | 1987-05-26 |