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510(k) K123343

THERMO SCIENTIFIC QMS TACROLIMUS ASSAY AND CALIBRATORS by Microgenics Corp. — Product Code MLM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 11, 2013
Date Received
October 31, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Immunoassay, Tracrolimus
Device Class
Class II
Regulation Number
862.1678
Review Panel
TX
Submission Type

Other clearances by Microgenics Corp.

  • K122766 — THERMO SCIENTIFIC QMS EVEROLIMUS ASSAY (August 20, 2013)
  • K123271 — ABBOTT PHENOBARBITAL ASSAY (April 26, 2013)
  • K110616 — THERMO SCIENTIFIC MAS OMNI-IMMUNE, MAS OMNI IMMUNE PRO (June 29, 2011)
  • 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 MLM

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  • K173857 — Elecsys Tacrolimus (November 6, 2018)
  • K150168 — Dimension Tacrolimus Flex® Reagent Cartridge (TAC), Dimension Tacrolimus Calibra (November 4, 2015)
  • K070820 — ARCHITECT TACROLIMUS: MODEL 1L77 (August 1, 2007)
  • K063868 — MASSTRAK IMMUNOSUPPRESSANTS KIT (May 25, 2007)
  • K060502 — DIMENSION TACR FLEX REAGENT CARTRIDGE, MODEL DF107 (May 18, 2006)
  • K060385 — EMIT 2000 TACROLIMUS ASSAY AND SAMPLE PRETREATMENT REAGENT (April 6, 2006)
  • K050206 — CEDIA TACROLIMUS ASSAY (March 15, 2005)