The following data is part of a premarket notification filed by Roseville Medical Laboratoriesu with the FDA for Differential Culture Medium.
Device ID | K850734 |
510k Number | K850734 |
Device Name: | DIFFERENTIAL CULTURE MEDIUM |
Classification | Culture Media, Multiple Biochemical Test |
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 | JSE |
CFR Regulation Number | 866.2320 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-02-20 |
Decision Date | 1985-03-20 |