The following data is part of a premarket notification filed by Ventrex Laboratories, Inc. with the FDA for Vast Ventrex Rast Allergen Discs.
| Device ID | K822442 |
| 510k Number | K822442 |
| Device Name: | VAST VENTREX RAST ALLERGEN DISCS |
| 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 | 1982-08-16 |
| Decision Date | 1982-09-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816879022285 | K822442 | 000 |
| 00816879021394 | K822442 | 000 |
| 00816879021448 | K822442 | 000 |
| 00816879021455 | K822442 | 000 |
| 00816879021622 | K822442 | 000 |
| 00816879021691 | K822442 | 000 |
| 00816879021752 | K822442 | 000 |
| 00816879021813 | K822442 | 000 |
| 00816879021936 | K822442 | 000 |
| 00816879021943 | K822442 | 000 |
| 00816879021981 | K822442 | 000 |
| 00816879022063 | K822442 | 000 |
| 00816879021158 | K822442 | 000 |