Home / 510(k) Clearances / K110738

510(k) K110738

THERMO SCIENTIFIC MAS OMNI-CORE by Microgenics Corporation — Product Code JJY

K110738 is an FDA 510(k) premarket notification submitted by Microgenics Corporation for the device "THERMO SCIENTIFIC MAS OMNI-CORE". The FDA issued a decision of Substantially Equivalent on November 3, 2011. The device falls under product code JJY (Multi-Analyte Controls, All Kinds (Assayed)), a Class I device regulated under 21 CFR 862.1660. Microgenics Corporation has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 3, 2011
Date Received
March 17, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Multi-Analyte Controls, All Kinds (Assayed)
Device Class
Class I
Regulation Number
862.1660
Review Panel
CH
Submission Type

Other clearances by Microgenics Corporation

  • K243498 — Alinity c Benzodiazepines Reagent Kit (December 11, 2024)
  • K240670 — DRI Ecstasy Plus Assay (October 30, 2024)
  • K231020 — Alinity c Tricyclic Antidepressants Reagent Kit (November 17, 2023)
  • K231007 — CEDIA Heroin Metabolite (6-AM) Assay (September 27, 2023)
  • K213875 — DRI TM Tricyclics Serum Tox Assay (December 21, 2022)
  • K211973 — DRI Cocaine Metabolite Assay (September 24, 2021)
  • K192943 — CEDIA Heroin Metabolite (6-AM) assay (December 16, 2019)
  • K190968 — CEDIA Benzodiazepine Assay (December 9, 2019)
  • DEN180030 — QMS Plazomicin Immunoassay (November 19, 2018)
  • K181499 — DRI Cocaine Metabolite Assay (July 6, 2018)

Other clearances for product code JJY

  • K162530 — Multichem IA Plus (March 31, 2017)
  • K163629 — Audit MicroControls Linearity FD Tumor Markers II (March 10, 2017)
  • K163015 — Liquichek Tumor Marker Control-Level 1; Liquichek Tumor Marker Control-Level 2; (January 10, 2017)
  • K153712 — VK-3 Verification Kit, VK-4 Verification Kit, VK-R5 Verification Kit, VK-R7 Veri (January 28, 2016)
  • K150300 — Liquichek Cardiac Markers Plus Control LT (December 11, 2015)
  • K142964 — VALIDATE Anemia Calibration Verification/ Linearity Test Kit (April 30, 2015)
  • K143379 — Liquichek Maternal Serum II Control (March 13, 2015)
  • K143573 — Audit MicroControls Linearity FD Tumor Markers II (January 16, 2015)
  • K140971 — LIQUID ASSAYED CHEMISTRY CONTROL PREMIUM PLUS LEVEL 1,2 AND LEVEL 3. (December 8, 2014)
  • K142978 — Audit MicroControls Linearity LQ Special Diabetes (November 20, 2014)

FDA data resources