Ids-Isys Ifg-I Control Set
FDA 510(k) K110412 · Immunodiagnostic Systems , Ltd.
510(k) numberK110412
Submission
- Device name
- Ids-Isys Ifg-I Control Set
- Applicant
- Immunodiagnostic Systems , Ltd.
Boldon, Tyne & Wear, GB - Received
- February 14, 2011
- Decision date
- March 16, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 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 Ids-Isys Ifg-I Control Set cleared by the FDA?
Ids-Isys Ifg-I Control Set (K110412) received a 510(k) decision of Substantially Equivalent on March 16, 2011, 30 days after the submission was received.
What is the product code of K110412?
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.