Architect Dhea-S Calibrators (A-F) and Controls (Low, Medium and High)
FDA 510(k) K060027 · Biokit, S.A.
510(k) numberK060027
Submission
- Device name
- Architect Dhea-S Calibrators (A-F) and Controls (Low, Medium and High)
- Applicant
- Biokit, S.A.
Barcelona, ES - Received
- January 4, 2006
- Decision date
- January 26, 2006
- 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 Architect Dhea-S Calibrators (A-F) and Controls (Low, Medium and High) cleared by the FDA?
Architect Dhea-S Calibrators (A-F) and Controls (Low, Medium and High) (K060027) received a 510(k) decision of Substantially Equivalent on January 26, 2006, 22 days after the submission was received.
What is the product code of K060027?
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.