Normal and Hypergamma Control Serum
FDA 510(k) K040925 · Sebia
510(k) numberK040925
Submission
- Device name
- Normal and Hypergamma Control Serum
- Applicant
- Sebia
Chelsea, MI, US - Received
- April 8, 2004
- Decision date
- April 28, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- JJY – Multi-Analyte Controls, All Kinds (Assayed)
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1660
- Specialty
- Clinical Chemistry
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Questions and answers
When was Normal and Hypergamma Control Serum cleared by the FDA?
Normal and Hypergamma Control Serum (K040925) received a 510(k) decision of Substantially Equivalent on April 28, 2004, 20 days after the submission was received.
What is the product code of K040925?
The FDA product code is JJY – Multi-Analyte Controls, All Kinds (Assayed), a Class I (low risk) device regulated under 21 CFR 862.1660.