Elecsys Ck-Mb Calcheck 5
FDA 510(k) K093582 · Roche Diagnostics
510(k) numberK093582
Submission
- Device name
- Elecsys Ck-Mb Calcheck 5
- Applicant
- Roche Diagnostics
Indianapolis, IN, US - Received
- November 19, 2009
- Decision date
- March 29, 2010
- 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 Elecsys Ck-Mb Calcheck 5 cleared by the FDA?
Elecsys Ck-Mb Calcheck 5 (K093582) received a 510(k) decision of Substantially Equivalent on March 29, 2010, 130 days after the submission was received.
What is the product code of K093582?
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.