The following data is part of a premarket notification filed by Hycor Biomedical, Inc. with the FDA for White Ash - Fraxinus Americana (t15) Allergen Disc.
Device ID | K921574 |
510k Number | K921574 |
Device Name: | WHITE ASH - FRAXINUS AMERICANA (T15) 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 | 1992-04-02 |
Decision Date | 1992-08-03 |