The following data is part of a premarket notification filed by Ventrex Laboratories, Inc. with the FDA for New Allergen Disc -vast Ventex Allergy.
| Device ID | K831091 |
| 510k Number | K831091 |
| Device Name: | NEW ALLERGEN DISC -VAST VENTEX ALLERGY |
| Classification | System, Test, Radioallergosorbent (rast) Immunological |
| Applicant | VENTREX LABORATORIES, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | DHB |
| CFR Regulation Number | 866.5750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-04-04 |
| Decision Date | 1983-04-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816879022032 | K831091 | 000 |
| 00816879021363 | K831091 | 000 |
| 00816879021370 | K831091 | 000 |
| 00816879021486 | K831091 | 000 |
| 00816879021516 | K831091 | 000 |
| 00816879021578 | K831091 | 000 |
| 00816879021660 | K831091 | 000 |
| 00816879021714 | K831091 | 000 |
| 00816879021851 | K831091 | 000 |
| 00816879021967 | K831091 | 000 |
| 00816879021271 | K831091 | 000 |