The following data is part of a premarket notification filed by Ventrex Laboratories, Inc. with the FDA for Vast Ventrex Allergy Systems Tests.
| Device ID | K821451 | 
| 510k Number | K821451 | 
| Device Name: | VAST VENTREX ALLERGY SYSTEMS TESTS | 
| Classification | System, Test, Radioallergosorbent (rast) Immunological | 
| Applicant | VENTREX LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 | 
| Product Code | DHB | 
| CFR Regulation Number | 866.5750 [🔎] | 
| Decision | Substantially Equivalent (SESE) | 
| Type | Traditional | 
| 3rd Party Reviewed | No | 
| Combination Product | No | 
| Date Received | 1982-05-14 | 
| Decision Date | 1982-06-23 | 
| Device Identifier | submissionNumber | Supplement | 
|---|---|---|
| 00816879022056 | K821451 | 000 | 
| 00816879021530 | K821451 | 000 | 
| 00816879021493 | K821451 | 000 | 
| 00816879021431 | K821451 | 000 | 
| 00816879021424 | K821451 | 000 | 
| 00816879021417 | K821451 | 000 | 
| 00816879021400 | K821451 | 000 | 
| 00816879021189 | K821451 | 000 | 
| 00816879021172 | K821451 | 000 | 
| 00816879021141 | K821451 | 000 | 
| 00816879021554 | K821451 | 000 | 
| 00816879021585 | K821451 | 000 | 
| 00816879022049 | K821451 | 000 | 
| 00816879021745 | K821451 | 000 | 
| 00816879021721 | K821451 | 000 | 
| 00816879021707 | K821451 | 000 | 
| 00816879021684 | K821451 | 000 | 
| 00816879021646 | K821451 | 000 | 
| 00816879021639 | K821451 | 000 | 
| 00816879021615 | K821451 | 000 | 
| 00816879021608 | K821451 | 000 | 
| 00816879022865 | K821451 | 000 |