The following data is part of a premarket notification filed by Quidel Corp. with the FDA for Quidel Helicobacter Pylori Microwell Eia Test.
| Device ID | K912442 |
| 510k Number | K912442 |
| Device Name: | QUIDEL HELICOBACTER PYLORI MICROWELL EIA TEST |
| Classification | Helicobacter Pylori |
| Applicant | QUIDEL CORP. 10165 MCKELLAR COURT San Diego, CA 92121 |
| Contact | Craig E Watson |
| Correspondent | Craig E Watson QUIDEL CORP. 10165 MCKELLAR COURT San Diego, CA 92121 |
| Product Code | LYR |
| CFR Regulation Number | 866.3110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-06-03 |
| Decision Date | 1991-09-16 |