The following data is part of a premarket notification filed by Nobel Scientific Industries, Inc. with the FDA for Nsi Chloride Reagent Kit.
Device ID | K800585 |
510k Number | K800585 |
Device Name: | NSI CHLORIDE REAGENT KIT |
Classification | Coulometric, Chloride |
Applicant | NOBEL SCIENTIFIC INDUSTRIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | JFS |
CFR Regulation Number | 862.1170 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1980-03-17 |
Decision Date | 1980-04-02 |