The following data is part of a premarket notification filed by Ventrex, Inc. with the FDA for Ventrex Allergen Disc.
Device ID | K925044 |
510k Number | K925044 |
Device Name: | VENTREX ALLERGEN DISC |
Classification | System, Test, Radioallergosorbent (rast) Immunological |
Applicant | VENTREX, INC. 217 READ ST. P.O. BOX 9731 Portland, ME 04104 |
Contact | Anne Jepson |
Correspondent | Anne Jepson VENTREX, INC. 217 READ ST. P.O. BOX 9731 Portland, ME 04104 |
Product Code | DHB |
CFR Regulation Number | 866.5750 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-10-05 |
Decision Date | 1993-05-14 |