The following data is part of a premarket notification filed by Hycor Biomedical, Inc. with the FDA for Pyloragen Helicbacter Pylori Test Kit - Modified.
| Device ID | K923445 |
| 510k Number | K923445 |
| Device Name: | PYLORAGEN HELICBACTER PYLORI TEST KIT - MODIFIED |
| Classification | Helicobacter Pylori |
| Applicant | HYCOR BIOMEDICAL, INC. 7572 CHAPMAN AVE. Garden Grove, CA 92641 |
| Contact | Ronald Hoover |
| Correspondent | Ronald Hoover HYCOR BIOMEDICAL, INC. 7572 CHAPMAN AVE. Garden Grove, CA 92641 |
| Product Code | LYR |
| CFR Regulation Number | 866.3110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-07-08 |
| Decision Date | 1992-09-11 |