The following data is part of a premarket notification filed by Corning Medical & Scientific with the FDA for C/n Screen.
Device ID | K790119 |
510k Number | K790119 |
Device Name: | C/N SCREEN |
Classification | Culture Media, Selective And Differential |
Applicant | CORNING MEDICAL & SCIENTIFIC 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | JSI |
CFR Regulation Number | 866.2360 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-01-23 |
Decision Date | 1979-03-08 |