The following data is part of a premarket notification filed by American Monitor Corp. with the FDA for American Monitor Magnesium #'s 1036&4021.
Device ID | K802091 |
510k Number | K802091 |
Device Name: | AMERICAN MONITOR MAGNESIUM #'S 1036&4021 |
Classification | Photometric Method, Magnesium |
Applicant | AMERICAN MONITOR CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | JGJ |
CFR Regulation Number | 862.1495 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1980-09-02 |
Decision Date | 1980-10-10 |