The following data is part of a premarket notification filed by Roseville Medical Laboratoriesu with the FDA for Selective Culture Medium.
Device ID | K850736 |
510k Number | K850736 |
Device Name: | SELECTIVE CULTURE MEDIUM |
Classification | Culture Media, Selective And Differential |
Applicant | ROSEVILLE MEDICAL LABORATORIESU 729 SUNRISE, BLVD. SUITE 600 Roseville, CA 95678 |
Contact | Larry R Mccain |
Correspondent | Larry R Mccain ROSEVILLE MEDICAL LABORATORIESU 729 SUNRISE, BLVD. SUITE 600 Roseville, CA 95678 |
Product Code | JSI |
CFR Regulation Number | 866.2360 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-02-20 |
Decision Date | 1985-03-20 |