The following data is part of a premarket notification filed by Technicon Instruments Corp. with the FDA for Technicon Ra Systems Sodium (colorimetric Method).
Device ID | K896829 |
510k Number | K896829 |
Device Name: | TECHNICON RA SYSTEMS SODIUM (COLORIMETRIC METHOD) |
Classification | Flame Photometry, Sodium |
Applicant | TECHNICON INSTRUMENTS CORP. 511 BENEDICT AVE. Tarrytown, NY 10591 |
Contact | C Brewster |
Correspondent | C Brewster TECHNICON INSTRUMENTS CORP. 511 BENEDICT AVE. Tarrytown, NY 10591 |
Product Code | JGT |
CFR Regulation Number | 862.1665 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-12-04 |
Decision Date | 1990-02-23 |