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 |