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 |