The following data is part of a premarket notification filed by Quidel Corp. with the FDA for Quickvue One-step H. Pylori Ii Test.
| Device ID | K991747 |
| 510k Number | K991747 |
| Device Name: | QUICKVUE ONE-STEP H. PYLORI II TEST |
| Classification | Helicobacter Pylori |
| Applicant | QUIDEL CORP. 10165 MCKELLAR CT. San Diego, CA 92121 |
| Contact | Robin Weiner |
| Correspondent | Robin Weiner QUIDEL CORP. 10165 MCKELLAR CT. 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 | 1999-05-21 |
| Decision Date | 1999-08-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30014613320104 | K991747 | 000 |
| 30014613320098 | K991747 | 000 |