The following data is part of a premarket notification filed by Hycor Biomedical, Inc. with the FDA for Hy-tec Specific And Total Ige Eia System.
| Device ID | K081217 |
| 510k Number | K081217 |
| Device Name: | HY-TEC SPECIFIC AND TOTAL IGE EIA SYSTEM |
| 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 | 2008-04-30 |
| Decision Date | 2008-05-22 |
| Summary: | summary |