510(k) K150132
K150132 is an FDA 510(k) premarket notification submitted by Siemens Healthcare Diagnostics for the device "IMMULITE IGF Control Module, IMMULITE Gastrin Control Module". The FDA issued a decision of Substantially Equivalent on April 13, 2015. The device falls under product code JJX (Single (Specified) Analyte Controls (Assayed And Unassayed)), a Class I device regulated under 21 CFR 862.1660. Siemens Healthcare Diagnostics has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 13, 2015
- Date Received
- January 21, 2015
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Single (Specified) Analyte Controls (Assayed And Unassayed)
- Device Class
- Class I
- Regulation Number
- 862.1660
- Review Panel
- CH
- Submission Type