The following data is part of a premarket notification filed by Hycor Biomedical, Inc. with the FDA for Hycor Allergen Disc.
| Device ID | K965094 |
| 510k Number | K965094 |
| Device Name: | HYCOR ALLERGEN DISC |
| Classification | System, Test, Radioallergosorbent (rast) Immunological |
| Applicant | HYCOR BIOMEDICAL, INC. 7272 CHAPMAN AVE. Garden Grove, CA 92841 |
| Contact | M. Alem, Ph.d. |
| Correspondent | M. Alem, Ph.d. HYCOR BIOMEDICAL, INC. 7272 CHAPMAN AVE. Garden Grove, CA 92841 |
| Product Code | DHB |
| CFR Regulation Number | 866.5750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-12-19 |
| Decision Date | 1997-05-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816879021820 | K965094 | 000 |