The following data is part of a premarket notification filed by Quidel Corp. with the FDA for Quickvue One-step Helicobactor Pylori Test.
| Device ID | K952517 |
| 510k Number | K952517 |
| Device Name: | QUICKVUE ONE-STEP HELICOBACTOR PYLORI TEST |
| Classification | Helicobacter Pylori |
| Applicant | QUIDEL CORP. 10165 MCKELLAR COURT San Diego, CA 92121 |
| Contact | Robin Weiner |
| Correspondent | Robin Weiner 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 | 1995-05-31 |
| Decision Date | 1996-02-06 |