The following data is part of a premarket notification filed by Quidel Corp. with the FDA for Quidel Quickvue H. Pylori Controls (pos. And Neg).
| Device ID | K915851 |
| 510k Number | K915851 |
| Device Name: | QUIDEL QUICKVUE H. PYLORI CONTROLS (POS. AND NEG) |
| Classification | Helicobacter Pylori |
| Applicant | QUIDEL CORP. 10165 MCKELLAR COURT San Diego, CA 92121 |
| Contact | Craig Watson |
| Correspondent | Craig 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 | 1991-12-27 |
| Decision Date | 1992-02-21 |