The following data is part of a premarket notification filed by Roseville Medical Laboratoriesu with the FDA for Culture Medium For Pathogenic Neisseria Ssp.mi.
| Device ID | K850732 |
| 510k Number | K850732 |
| Device Name: | CULTURE MEDIUM FOR PATHOGENIC NEISSERIA SSP.MI |
| Classification | Culture Media, For Isolation Of Pathogenic Neisseria |
| 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 | JTY |
| CFR Regulation Number | 866.2410 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-02-20 |
| Decision Date | 1985-03-20 |