The following data is part of a premarket notification filed by Bioteque America, Inc. with the FDA for Versa-vial.
| Device ID | K920177 |
| 510k Number | K920177 |
| Device Name: | VERSA-VIAL |
| Classification | Actuator, Syringe, Injector Type |
| Applicant | BIOTEQUE AMERICA, INC. 51 RAINLILY RD. Levittown, PA 19056 |
| Contact | Denis Dorsey |
| Correspondent | Denis Dorsey BIOTEQUE AMERICA, INC. 51 RAINLILY RD. Levittown, PA 19056 |
| Product Code | DQF |
| CFR Regulation Number | 870.1670 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-01-14 |
| Decision Date | 1992-07-13 |