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510(k) K122766

THERMO SCIENTIFIC QMS EVEROLIMUS ASSAY by Microgenics Corp. — Product Code OUF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 20, 2013
Date Received
September 10, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Everolimus Immunoassay
Device Class
Class II
Regulation Number
862.3840
Review Panel
TX
Submission Type

To quantify everolimus in whole blood.

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  • K101754 — THERMO SCIENTIFIC CEDIA OPIATE OFT ASSAY (April 8, 2011)
  • K101744 — THERMO SCIENTIFIC CEDIA CANNABINOIDS OFT ASSAY (April 8, 2011)
  • K101753 — THERMO SCIENTIFIC CEDIA METHAMPHETAMINE OFT ASSAY (April 8, 2011)
  • K101742 — THERMO SCIENTIFIC CEDIA COCAINE OFT ASSAY (April 8, 2011)
  • K101746 — THERMO SCIENTIFIC CEDIA PHENCYCLIDINE (PCP) OFT ASSAY (April 8, 2011)
  • K101752 — THERMO SCIENTIFIC CEDIA MULTI-DRUG OFT CALIBRATORS (April 8, 2011)
  • K101745 — THERMO SCIENTIFIC CEDIA AMPHETAMINE OFT ASSAY (April 8, 2011)

Other clearances for product code OUF

  • K100144 — THERMO SCIENTIFIC QMS EVEROLIMUS REAGENTS, CALIBRATORS AND CONTROLS (February 11, 2011)