Quickvue Advance PH and Amines GLL Test
FDA 510(k) K040008 · Quidel Corp.
510(k) numberK040008
Submission
- Device name
- Quickvue Advance PH and Amines GLL Test
- Applicant
- Quidel Corp.
San Diego, CA, US - Received
- January 2, 2004
- Decision date
- April 29, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CEN – Dye-Indicator, Ph (Urinary, Non-Quantitative)
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1550
- Specialty
- Clinical Chemistry
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Questions and answers
When was Quickvue Advance PH and Amines GLL Test cleared by the FDA?
Quickvue Advance PH and Amines GLL Test (K040008) received a 510(k) decision of Substantially Equivalent on April 29, 2004, 118 days after the submission was received.
What is the product code of K040008?
The FDA product code is CEN – Dye-Indicator, Ph (Urinary, Non-Quantitative), a Class I (low risk) device regulated under 21 CFR 862.1550.