The following data is part of a premarket notification filed by Hycor Biomedical, Inc. with the FDA for Hycor Specific Ige Enzyme Immunoassay.
| Device ID | K945748 |
| 510k Number | K945748 |
| Device Name: | HYCOR SPECIFIC IGE ENZYME IMMUNOASSAY |
| Classification | System, Test, Radioallergosorbent (rast) Immunological |
| Applicant | HYCOR BIOMEDICAL, INC. 7272 CHAPMAN AVE. Garden Grove, CA 92841 |
| Contact | Jim Tung |
| Correspondent | Jim Tung 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 | 1994-11-23 |
| Decision Date | 1995-06-07 |