The following data is part of a premarket notification filed by General Diagnostics with the FDA for General Diag. Cefonicid 30mcg Antimic.
Device ID | K842307 |
510k Number | K842307 |
Device Name: | GENERAL DIAG. CEFONICID 30MCG ANTIMIC |
Classification | Susceptibility Test Discs, Antimicrobial |
Applicant | GENERAL DIAGNOSTICS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | JTN |
CFR Regulation Number | 866.1620 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-06-12 |
Decision Date | 1984-07-20 |