Milenia Data Reduction
FDA 510(k) K915806 · Diagnostic Products Corp.
510(k) numberK915806
Submission
- Device name
- Milenia Data Reduction
- Applicant
- Diagnostic Products Corp.
Los Angeles, CA, US - Received
- December 24, 1991
- Decision date
- January 30, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 Milenia Data Reduction cleared by the FDA?
Milenia Data Reduction (K915806) received a 510(k) decision of Substantially Equivalent on January 30, 1992, 37 days after the submission was received.
What is the product code of K915806?
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.