The following data is part of a premarket notification filed by Quidel Corp. with the FDA for Quickvue One-step Allergen Screen.
| Device ID | K950728 |
| 510k Number | K950728 |
| Device Name: | QUICKVUE ONE-STEP ALLERGEN SCREEN |
| Classification | System, Test, Radioallergosorbent (rast) Immunological |
| Applicant | QUIDEL CORP. 10165 MCKELLAR COURT San Diego, CA 92121 |
| Contact | Joe Mcmullen |
| Correspondent | Joe Mcmullen QUIDEL CORP. 10165 MCKELLAR COURT San Diego, CA 92121 |
| Product Code | DHB |
| CFR Regulation Number | 866.5750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-02-16 |
| Decision Date | 1995-10-02 |