The following data is part of a premarket notification filed by American Monitor Corp. with the FDA for Tptz Chloride.
Device ID | K820235 |
510k Number | K820235 |
Device Name: | TPTZ CHLORIDE |
Classification | Mercuric Thiocyanate, Colorimetry, Chloride |
Applicant | AMERICAN MONITOR CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | CHJ |
CFR Regulation Number | 862.1170 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-01-28 |
Decision Date | 1982-02-12 |