Audit Microcv Homocysteine Linearity Set, Model 704M-5
FDA 510(k) K100715 · Aalto Scientific, Ltd.
510(k) numberK100715
Submission
- Device name
- Audit Microcv Homocysteine Linearity Set, Model 704M-5
- Applicant
- Aalto Scientific, Ltd.
Carlsbad, CA, US - Received
- March 12, 2010
- Decision date
- December 23, 2010
- 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 Audit Microcv Homocysteine Linearity Set, Model 704M-5 cleared by the FDA?
Audit Microcv Homocysteine Linearity Set, Model 704M-5 (K100715) received a 510(k) decision of Substantially Equivalent on December 23, 2010, 286 days after the submission was received.
What is the product code of K100715?
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.