The following data is part of a premarket notification filed by Bioclinical Systems, Inc. with the FDA for Culture Media, For Isolation Of Pathogenic Neisseria.
| Device ID | K950196 |
| 510k Number | K950196 |
| Device Name: | CULTURE MEDIA, FOR ISOLATION OF PATHOGENIC NEISSERIA |
| Classification | Culture Media, For Isolation Of Pathogenic Neisseria |
| Applicant | BIOCLINICAL SYSTEMS, INC. 9040 JUNCTION DR. Annapolis Junction, MD 20701 |
| Contact | Kathryn B Powers |
| Correspondent | Kathryn B Powers BIOCLINICAL SYSTEMS, INC. 9040 JUNCTION DR. Annapolis Junction, MD 20701 |
| Product Code | JTY |
| CFR Regulation Number | 866.2410 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-01-18 |
| Decision Date | 1995-06-30 |