The following data is part of a premarket notification filed by Sclavo, Inc. with the FDA for Calcium Reagent Sys.
Device ID | K840214 |
510k Number | K840214 |
Device Name: | CALCIUM REAGENT SYS |
Classification | Di (o-hydroxyphenylimine) Ethane, Calcium |
Applicant | SCLAVO, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | CHZ |
CFR Regulation Number | 862.1145 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-01-19 |
Decision Date | 1984-03-19 |