IMMULITE IGF Control Module, IMMULITE Gastrin Control Module
FDA 510(k) K150132 · Siemens Healthcare Diagnostics
510(k) numberK150132
Submission
- Device name
- IMMULITE IGF Control Module, IMMULITE Gastrin Control Module
- Applicant
- Siemens Healthcare Diagnostics
Tarrytown, NY, US - Received
- January 21, 2015
- Decision date
- April 13, 2015
- 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 IMMULITE IGF Control Module, IMMULITE Gastrin Control Module cleared by the FDA?
IMMULITE IGF Control Module, IMMULITE Gastrin Control Module (K150132) received a 510(k) decision of Substantially Equivalent on April 13, 2015, 82 days after the submission was received.
What is the product code of K150132?
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.