The following data is part of a premarket notification filed by Hycor Biomedical, Inc. with the FDA for Ventrex Allergen Disc.
| Device ID | K922538 |
| 510k Number | K922538 |
| Device Name: | VENTREX ALLERGEN DISC |
| Classification | System, Test, Radioallergosorbent (rast) Immunological |
| Applicant | HYCOR BIOMEDICAL, INC. 217 READ ST. Portland, ME 04103 |
| Contact | Anne Jepson |
| Correspondent | Anne Jepson HYCOR BIOMEDICAL, INC. 217 READ ST. Portland, ME 04103 |
| Product Code | DHB |
| CFR Regulation Number | 866.5750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-05-29 |
| Decision Date | 1992-07-27 |