The following data is part of a premarket notification filed by Clinical Sciences, Inc. with the FDA for Martin Lewis Agar Csi 3169.
Device ID | K791447 |
510k Number | K791447 |
Device Name: | MARTIN LEWIS AGAR CSI 3169 |
Classification | Culture Media, For Isolation Of Pathogenic Neisseria |
Applicant | CLINICAL SCIENCES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | JTY |
CFR Regulation Number | 866.2410 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-07-31 |
Decision Date | 1979-09-17 |