The following data is part of a premarket notification filed by Quidel Corp. with the FDA for Quickvue One-step Hcg-combo.
| Device ID | K020801 |
| 510k Number | K020801 |
| Device Name: | QUICKVUE ONE-STEP HCG-COMBO |
| Classification | Visual, Pregnancy Hcg, Prescription Use |
| Applicant | QUIDEL CORP. 10165 MCKELLAR CT. San Diego, CA 92121 |
| Contact | Jennifer S Hankard |
| Correspondent | Jennifer S Hankard QUIDEL CORP. 10165 MCKELLAR CT. San Diego, CA 92121 |
| Product Code | JHI |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-03-12 |
| Decision Date | 2002-05-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30014613201106 | K020801 | 000 |