The following data is part of a premarket notification filed by Mid Tech, Inc. with the FDA for Ars, Chemistry.
Device ID | K791313 |
510k Number | K791313 |
Device Name: | ARS, CHEMISTRY |
Classification | Multi-analyte Controls, All Kinds (assayed) |
Applicant | MID TECH, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | JJY |
CFR Regulation Number | 862.1660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-07-12 |
Decision Date | 1979-08-16 |