The following data is part of a premarket notification filed by Diagnostic Solutions, Inc. with the FDA for Reagent For Determ. Chloride In Human/sm.
Device ID | K800683 |
510k Number | K800683 |
Device Name: | REAGENT FOR DETERM. CHLORIDE IN HUMAN/SM |
Classification | Mercuric Thiocyanate, Colorimetry, Chloride |
Applicant | DIAGNOSTIC SOLUTIONS, INC. 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 | 1980-03-26 |
Decision Date | 1980-05-28 |