THERMO SCIENTIFIC MAS OMNI-IMMUNE, MAS OMNI IMMUNE PRO— 510(k) K110616
Substantially EquivalentMicrogenics Corp.
FDA 510(k) clearance K110616 for THERMO SCIENTIFIC MAS OMNI-IMMUNE, MAS OMNI IMMUNE PRO, Substantially Equivalent on 2011-06-29. Applicant: Microgenics Corp.. Device class: 1.
Clearance details
- Applicant
- Microgenics Corp.
- Product code
- Code JJY
- Device class
- Class 1
- Regulation
- 21 CFR 862.1660
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Fremont Blvd., CA, US
Recent devices under product code JJY
view all- K162530 — Multichem IA Plus
- K163629 — Audit MicroControls Linearity FD Tumor Markers II
- K163015 — Liquichek Tumor Marker Control-Level 1 +3 more
- K153712 — VK-3 Verification Kit, VK-4 Verification Kit, VK-R5 Verification Kit, VK-R7 Verification Kit, VK-Crea Verification Kit
- K150300 — Liquichek Cardiac Markers Plus Control LT
More clearances from Microgenics Corp.
view allRecalls naming K110616
K-number listed on FDA's recall record- Z-1929-2014 — MAS Omni Immune Controls
- Z-1930-2014 — MAS Omni Immune PRO Controls
- Z-0379-2013 — Thermo Scientific MAS Omni IMMUNE and Omni IMMUNE PRO; Liquid Assayed Integrated Immunoassay Control. Intended for use as an assayed control for monitoring assay conditions in many clinical laboratory determinations. Assay values are provided for the specific systems listed. The user can compare observations with expected ranges as a means of assuring consistent performance or reagent and instrument. .
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K110616.
Data sourced from openFDA. This site is unofficial and independent of the FDA.