Elecsys Probnp Calcheck
FDA 510(k) K020883 · Roche Diagnostics Corp.
510(k) numberK020883
Submission
- Device name
- Elecsys Probnp Calcheck
- Applicant
- Roche Diagnostics Corp.
Indianapolis, IN, US - Received
- March 18, 2002
- Decision date
- November 29, 2002
- 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 Elecsys Probnp Calcheck cleared by the FDA?
Elecsys Probnp Calcheck (K020883) received a 510(k) decision of Substantially Equivalent on November 29, 2002, 256 days after the submission was received.
What is the product code of K020883?
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.