The following data is part of a premarket notification filed by Technicon Instruments Corp. with the FDA for Technicon Chem I System Magnesium Method.
Device ID | K903306 |
510k Number | K903306 |
Device Name: | TECHNICON CHEM I SYSTEM MAGNESIUM METHOD |
Classification | Photometric Method, Magnesium |
Applicant | TECHNICON INSTRUMENTS CORP. 511 BENEDICT AVE. Tarrytown, NY 10591 |
Contact | Thomas C Brewster |
Correspondent | Thomas C Brewster 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 | 1990-07-24 |
Decision Date | 1990-08-29 |