The following data is part of a premarket notification filed by Hycor Biomedical, Inc. with the FDA for Hy-tec Total Ige Enzyme Immunoassay.
| Device ID | K940183 |
| 510k Number | K940183 |
| Device Name: | HY-TEC TOTAL IGE ENZYME IMMUNOASSAY |
| Classification | Ige, Antigen, Antiserum, Control |
| Applicant | HYCOR BIOMEDICAL, INC. 7572 CHAPMAN AVE. Garden Grove, CA 92641 |
| Contact | Thomas J Foley |
| Correspondent | Thomas J Foley HYCOR BIOMEDICAL, INC. 7572 CHAPMAN AVE. Garden Grove, CA 92641 |
| Product Code | DGC |
| CFR Regulation Number | 866.5510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-01-12 |
| Decision Date | 1994-05-17 |