The following data is part of a premarket notification filed by Hycor Biomedical, Inc. with the FDA for Hycor Pyloragen Helicobacter Pylori Test.
| Device ID | K912255 |
| 510k Number | K912255 |
| Device Name: | HYCOR PYLORAGEN HELICOBACTER PYLORI TEST |
| Classification | Helicobacter Pylori |
| Applicant | HYCOR BIOMEDICAL, INC. 7272 CHAPMAN AVE. Garden Grove, CA 92841 |
| Contact | Ron Hoover |
| Correspondent | Ron Hoover HYCOR BIOMEDICAL, INC. 7272 CHAPMAN AVE. Garden Grove, CA 92841 |
| Product Code | LYR |
| CFR Regulation Number | 866.3110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-05-22 |
| Decision Date | 1991-10-11 |