Ids-Isys Igf-I Calibration Verifiers
FDA 510(k) K122141 · Immunodiagnostic Systems , Ltd.
510(k) numberK122141
Submission
- Device name
- Ids-Isys Igf-I Calibration Verifiers
- Applicant
- Immunodiagnostic Systems , Ltd.
Boldon, Tyne & Wear, GB - Received
- July 19, 2012
- Decision date
- August 7, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 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 Ids-Isys Igf-I Calibration Verifiers cleared by the FDA?
Ids-Isys Igf-I Calibration Verifiers (K122141) received a 510(k) decision of Substantially Equivalent on August 7, 2012, 19 days after the submission was received.
What is the product code of K122141?
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.