The following data is part of a premarket notification filed by Hycor Biomedical, Inc. with the FDA for Hy*tec Extended Specific Ige Eia, Mcs Assay Using Tecan Freedom Evo Rsp 200.
| Device ID | K080322 |
| 510k Number | K080322 |
| Device Name: | HY*TEC EXTENDED SPECIFIC IGE EIA, MCS ASSAY USING TECAN FREEDOM EVO RSP 200 |
| Classification | System, Test, Radioallergosorbent (rast) Immunological |
| Applicant | HYCOR BIOMEDICAL, INC. 7272 CHAPMAN AVE. Garden Grove, CA 92841 |
| Contact | P. Narayan Nayak |
| Correspondent | P. Narayan Nayak HYCOR BIOMEDICAL, INC. 7272 CHAPMAN AVE. Garden Grove, CA 92841 |
| Product Code | DHB |
| CFR Regulation Number | 866.5750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-02-06 |
| Decision Date | 2008-03-05 |
| Summary: | summary |