Irma Trupoint Creatinine Control Kit
FDA 510(k) K050983 · International Technidyne Corporation
510(k) numberK050983
Submission
- Device name
- Irma Trupoint Creatinine Control Kit
- Applicant
- International Technidyne Corporation
Roseville, MN, US - Received
- April 19, 2005
- Decision date
- May 16, 2005
- 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 Irma Trupoint Creatinine Control Kit cleared by the FDA?
Irma Trupoint Creatinine Control Kit (K050983) received a 510(k) decision of Substantially Equivalent on May 16, 2005, 27 days after the submission was received.
What is the product code of K050983?
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.