The following data is part of a premarket notification filed by Quidel Corp. with the FDA for Quickvue Advance Ph And Amines Gll Test.
| Device ID | K040008 |
| 510k Number | K040008 |
| Device Name: | QUICKVUE ADVANCE PH AND AMINES GLL TEST |
| Classification | Dye-indicator, Ph (urinary, Non-quantitative) |
| 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 | CEN |
| CFR Regulation Number | 862.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-01-02 |
| Decision Date | 2004-04-29 |
| Summary: | summary |