The following data is part of a premarket notification filed by Bioclinical Systems, Inc. with the FDA for Microbiological Culture Media,martin Lewis Agar.
| Device ID | K933122 |
| 510k Number | K933122 |
| Device Name: | MICROBIOLOGICAL CULTURE MEDIA,MARTIN LEWIS AGAR |
| Classification | Culture Media, For Isolation Of Pathogenic Neisseria |
| Applicant | BIOCLINICAL SYSTEMS, INC. 9040 JUNCTION DR. Annapolis Junction, MD 20701 |
| Contact | Kathryn Powers |
| Correspondent | Kathryn 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 | 1993-06-25 |
| Decision Date | 1994-02-09 |