The following data is part of a premarket notification filed by Hycor Biomedical, Inc. with the FDA for Specific Ige Eia-turbo Assay.
| Device ID | K925425 |
| 510k Number | K925425 |
| Device Name: | SPECIFIC IGE EIA-TURBO ASSAY |
| 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 | 1992-10-27 |
| Decision Date | 1993-01-14 |