The following data is part of a premarket notification filed by Sandare Chemical Co., Inc. with the FDA for Sandare Chloride Procedure.
Device ID | K792531 |
510k Number | K792531 |
Device Name: | SANDARE CHLORIDE PROCEDURE |
Classification | Mercuric Thiocyanate, Colorimetry, Chloride |
Applicant | SANDARE CHEMICAL CO., 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 | 1979-12-07 |
Decision Date | 1980-01-11 |