LIAISON CMV IgM Serum Control Set
FDA 510(k) K161526 · DiaSorin, Inc.
510(k) numberK161526
Submission
- Device name
- LIAISON CMV IgM Serum Control Set
- Applicant
- DiaSorin, Inc.
Stillwater, MN, US - Received
- June 2, 2016
- Decision date
- June 30, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 LIAISON CMV IgM Serum Control Set cleared by the FDA?
LIAISON CMV IgM Serum Control Set (K161526) received a 510(k) decision of Substantially Equivalent on June 30, 2016, 28 days after the submission was received.
What is the product code of K161526?
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.