The following data is part of a premarket notification filed by Bio Medicus, Inc. with the FDA for Urine Cultur Stabilization Transport Tube.
| Device ID | K920761 |
| 510k Number | K920761 |
| Device Name: | URINE CULTUR STABILIZATION TRANSPORT TUBE |
| Classification | Device, Specimen Collection |
| Applicant | BIO MEDICUS, INC. 50 WHITE MEADOW RD. Rockaway, NJ 07866 |
| Contact | Geppert Sr. |
| Correspondent | Geppert Sr. BIO MEDICUS, INC. 50 WHITE MEADOW RD. Rockaway, NJ 07866 |
| Product Code | LIO |
| CFR Regulation Number | 866.2900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-02-19 |
| Decision Date | 1992-06-19 |