The following data is part of a premarket notification filed by Ventrex Laboratories, Inc. with the FDA for New Allergen Discs For Use In Vast Vent.
| Device ID | K830817 |
| 510k Number | K830817 |
| Device Name: | NEW ALLERGEN DISCS FOR USE IN VAST VENT |
| Classification | Ige, Antigen, Antiserum, Control |
| Applicant | VENTREX LABORATORIES, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | DGC |
| CFR Regulation Number | 866.5510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-03-15 |
| Decision Date | 1983-04-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816879022018 | K830817 | 000 |
| 00816879021356 | K830817 | 000 |
| 00816879021349 | K830817 | 000 |
| 00816879021325 | K830817 | 000 |
| 00816879021295 | K830817 | 000 |
| 00816879021264 | K830817 | 000 |
| 00816879021257 | K830817 | 000 |
| 00816879021233 | K830817 | 000 |
| 00816879021226 | K830817 | 000 |
| 00816879021462 | K830817 | 000 |
| 00816879021479 | K830817 | 000 |
| 00816879021523 | K830817 | 000 |
| 00816879021998 | K830817 | 000 |
| 00816879021868 | K830817 | 000 |
| 00816879021844 | K830817 | 000 |
| 00816879021806 | K830817 | 000 |
| 00816879021738 | K830817 | 000 |
| 00816879021653 | K830817 | 000 |
| 00816879021561 | K830817 | 000 |
| 00816879021547 | K830817 | 000 |
| 00816879021219 | K830817 | 000 |