The following data is part of a premarket notification filed by Technicon Instruments Corp. with the FDA for Technicon Ra(tm) Systems - Magnesium.
Device ID | K883326 |
510k Number | K883326 |
Device Name: | TECHNICON RA(TM) SYSTEMS - MAGNESIUM |
Classification | Photometric Method, Magnesium |
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 | JGJ |
CFR Regulation Number | 862.1495 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-08-08 |
Decision Date | 1988-10-13 |