Fastpack Total Psa Method Verification Kit
FDA 510(k) K062957 · Qualigen, Inc.
510(k) numberK062957
Submission
- Device name
- Fastpack Total Psa Method Verification Kit
- Applicant
- Qualigen, Inc.
Carlsbad, CA, US - Received
- September 29, 2006
- Decision date
- April 2, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 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 Fastpack Total Psa Method Verification Kit cleared by the FDA?
Fastpack Total Psa Method Verification Kit (K062957) received a 510(k) decision of Substantially Equivalent on April 2, 2007, 185 days after the submission was received.
What is the product code of K062957?
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.