The following data is part of a premarket notification filed by Ventrex Laboratories, Inc. with the FDA for Nein Allergen Disc In Vast Ventrex Test.
| Device ID | K831554 |
| 510k Number | K831554 |
| Device Name: | NEIN ALLERGEN DISC IN VAST VENTREX TEST |
| 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 | 1983-05-13 |
| Decision Date | 1983-06-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816879022025 | K831554 | 000 |
| 00816879022001 | K831554 | 000 |
| 00816879021950 | K831554 | 000 |
| 00816879021790 | K831554 | 000 |
| 00816879021783 | K831554 | 000 |
| 00816879021677 | K831554 | 000 |
| 00816879021387 | K831554 | 000 |
| 00816879021332 | K831554 | 000 |
| 00816879021318 | K831554 | 000 |