The following data is part of a premarket notification filed by Ventrex Laboratories, Inc. with the FDA for Vast Ventrex Rast All.
| Device ID | K841651 |
| 510k Number | K841651 |
| Device Name: | VAST VENTREX RAST ALL |
| Classification | Ige, Antigen, Antiserum, Control |
| Applicant | VENTREX LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DGC |
| CFR Regulation Number | 866.5510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-04-20 |
| Decision Date | 1984-06-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816879021837 | K841651 | 000 |
| 00816879021776 | K841651 | 000 |
| 00816879021769 | K841651 | 000 |
| 00816879021301 | K841651 | 000 |
| 00816879021288 | K841651 | 000 |
| 00816879021240 | K841651 | 000 |