Quickvue(Tm) One-Step HCG Controls (Posit/Negati)
FDA 510(k) K931761 · Quidel Corp.
510(k) numberK931761
Submission
- Device name
- Quickvue(Tm) One-Step HCG Controls (Posit/Negati)
- Applicant
- Quidel Corp.
San Diego, CA, US - Received
- April 8, 1993
- Decision date
- June 22, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JJX – Single (Specified) Analyte Controls (Assayed And Unassayed)
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1660
- Specialty
- Clinical Chemistry
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Questions and answers
When was Quickvue(Tm) One-Step HCG Controls (Posit/Negati) cleared by the FDA?
Quickvue(Tm) One-Step HCG Controls (Posit/Negati) (K931761) received a 510(k) decision of Substantially Equivalent on June 22, 1993, 75 days after the submission was received.
What is the product code of K931761?
The FDA product code is JJX – Single (Specified) Analyte Controls (Assayed And Unassayed), a Class I (low risk) device regulated under 21 CFR 862.1660.